In the Clinic
Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2 S...
Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma
Matthew Stenger
On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label, p...
Daratumumab and Hyaluronidase-fihj for Multiple Myeloma
Matthew Stenger
On May 1, 2020, the combination of daratumumab and hyaluronidase-fihj was approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous (SC) dosing of daratumumab.1,2 Daratumumab and hyaluronidase-fihj is for SC use only. The prod...
Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications
Matthew Stenger
The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in metasta...
Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations
Matthew Stenger
On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of tum...
Ripretinib in Previously Treated Advanced Gastrointestinal Stromal Tumor
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 15, 2020, the receptor tyrosine kinase inhibitor r...
Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with enzalut...
Ramucirumab Plus Erlotinib in Treatment of EGFR-Mutant Metastatic NSCLC
Matthew Stenger
On May 29, 2020, ramucirumab was approved for use in combination with erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.1,2 Supporting Efficacy Data Approval was based on findings from the multina...
Pomalidomide for Treatment of Kaposi Sarcoma
Matthew Stenger
On May 14, 2020, pomalidomide was granted accelerated approval to treat adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and for Kaposi sarcoma in adult patients who are HIV-negative.1,2 Pomalidomide is available only through the restricted Pomaly...
Brigatinib for ALK-Positive Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On May 22, 2020, brigatinib was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diag...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
Matthew Stenger
On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected by...
Niraparib for First-Line Maintenance Treatment of Advanced Ovarian Cancer
Matthew Stenger
On April 29, 2020, niraparib was approved for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on ...
Sacituzumab Govitecan-hziy for Previously Treated Metastatic Triple-Negative Breast Cancer
Matthew Stenger
On April 22, 2020, the antibody-drug conjugate sacituzumab govitecan-hziy was granted accelerated approval for treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.1,2 Supporting Efficacy Data Approval was b...
Olaparib Plus Bevacizumab in Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Matthew Stenger
On May 8, 2020, olaparib was granted an expanded indication to include use in combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line plati...
Ibrutinib in Combination With Rituximab in Chronic Lymphocytic Leukemia
Matthew Stenger
On April 21, 2020, ibrutinib was granted an expanded indication for use in combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The recommended dosage of ibrutinib in CLL/SLL is 420 mg, once daily, unt...
Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
Matthew Stenger
On may 8, 2020, selpercatinib was granted accelerated approval for the following indications: Adult patients with metastatic RET fusion-positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who r...
Pemigatinib for Previously Treated Cholangiocarcinoma With FGFR2 Rearrangement or Fusion
Matthew Stenger
On April 17, 2020, pemigatinib was granted accelerated approval for the treatment of adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by a U.S. Food and Drug Admi...
Selumetinib for Pediatric Neurofibromatosis Type 1 With Symptomatic, Inoperable Plexiform Neurofibromas
Matthew Stenger
On April 10, 2020, the oral MEK inhibitor selumetinib was approved for the treatment of patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.1,2 Selumetinib is the first therapy approved for children who have this disease. Su...
Luspatercept-aamt for Anemia in Adults With Myelodysplastic Syndromes
Matthew Stenger
On April 3, 2020, luspatercept-aamt was approved in the treatment of anemia failing to respond to an erythropoiesis-stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks.1,2 The treatment is geared toward adult patients with very low– to intermediate-risk myelodysplastic ...
Tucatinib in Previously Treated HER2-Positive Metastatic Breast Cancer
Matthew Stenger
On April 17, 2020, tucatinib was approved for use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. These patients included those with brain metastases and those who have received one or more prior a...
Encorafenib Combined With Cetuximab in Previously Treated BRAF V600E–Mutant Metastatic Colorectal Cancer
Matthew Stenger
On April 8, 2020, encorafenib was approved for use in combination with cetuximab for the treatment of previously treated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Encorafenib is not indicated f...
Durvalumab Plus Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Matthew Stenger
On March 27, 2020, durvalumab (Imfinzi) was approved for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase I...
Isatuximab-irfc for Previously Treated Multiple Myeloma
Matthew Stenger
On March 2, 2020, the CD-38-directed cytolytic antibody isatuximab-irfc (Sarclisa) was approved for use in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1,2 Su...
Nivolumab/Ipilimumab in Patients With Sorafenib-Pretreated Hepatocellular Carcinoma
Matthew Stenger
On March 10, 2020, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was granted accelerated approval for treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.1-3 Supporting Efficacy Data The approval was based on findings in a cohort (coh...
Neratinib Combined With Capecitabine in Previously Treated Advanced HER2-Positive Breast Cancer
Matthew Stenger
On February 25, 2020, neratinib (Nerlynx) was approved for use in combination with capecitabine for treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting.1,2 Supporting Efficacy Data...
Avapritinib for Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation
Matthew Stenger
On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for patients...
Tazemetostat for Advanced Epithelioid Sarcoma
Matthew Stenger
On January 23, 2020, tazemetostat was granted accelerated approval for the treatment of adults and pediatric patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1,2 Supporting Efficacy Data Approval was based on the finding of dura...
Pembrolizumab for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer
Matthew Stenger
On January 8, 2020, pembrolizumab was approved for treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2 Suppo...
Olaparib as Maintenance Therapy for Germline BRCA-Mutated Metastatic Pancreatic Adenocarcinoma
Matthew Stenger
On December 27, 2019, the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib was approved for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma, as detected by a U.S. Food and Drug Administration (FDA)...
Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer
Matthew Stenger
On December 16, 2019, enzalutamide (Xtandi) was approved for the treatment of patients with metastatic castration-sensitive prostate cancer.1,2 Supporting Efficacy Data The current approval was based on findings from the phase III double-blind ARCHES trial (ClinicalTrials.gov identifier NCT0267789...
Atezolizumab With Chemotherapy for Metastatic Nonsquamous NSCLC Without EGFR/ALK Aberrations
Matthew Stenger
On December 3, 2019, atezolizumab in combination with nab-paclitaxel and carboplatin was approved for first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumore aberrations.1,2 The approval was based on findings in the open-label phase III I...
Fam-trastuzumab Deruxtecan-nxki for Previously Treated Unresectable or Metastatic HER2-Positive Breast Cancer
Matthew Stenger
On December 20, 2019, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was granted accelerated approval in the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting.1,2 Supp...
Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer
Matthew Stenger
On December 18, 2019, the antibody-drug conjugate enfortumab vedotin-ejfv (PadcevTM) was granted accelerated approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed cell dea...
Rituximab-abbs: Biosimilar to Rituximab for Non-Hodgkin Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Late in 2018, rituximab-abbs was approved as the first ...
Acalabrutinib for Adult Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Matthew Stenger
On November 21, 2019, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib was approved for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The review resulting in approval was conducted under Project Orbis, an initiative of the U.S. Food...
Pembrolizumab in Adjuvant Treatment of Melanoma With Involvement of Lymph Nodes After Complete Resection
Matthew Stenger
In early 2019, pembrolizumab was approved for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.1,2 Supporting Efficacy Data Approval was based on findings in the double-blind EORTC 1325/KEYNOTE-054 trial (ClinicalTrials.gov identifier ...
Gilteritinib for Relapsed or Refractory AML With FLT3 Mutation
Matthew Stenger
Late in 2018, the FLT3 inhibitor gilteritinib was approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved an expanded indication fo...
Trastuzumab and Hyaluronidase-oysk for Subcutaneous Use in HER2-Positive Breast Cancer
Matthew Stenger
Early in 2019, trastuzumab and the endoglycosidase hyaluronidase-oysk for subcutaneous injection was approved in the treatment of HER2-positive breast cancer.1,2 The agent is indicated for adjuvant treatment of patients with HER2-overexpressing node-positive or node-negative (estrogen receptor/proge...
Niraparib for Homologous Recombination Deficiency–Positive Advanced Ovarian Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 23, 2019, the poly (ADP-ribose) polymerase (PA...
First-Line Pembrolizumab Plus Axitinib for Advanced Renal Cell Carcinoma
The ASCO Post Staff
On April 19, 2019, pembrolizumab was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III KEYNOT...
Zanubrutinib in Previously Treated Mantle Cell Lymphoma
Matthew Stenger
On November 14, 2019, the oral Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib was granted accelerated approval in the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1,2 Supporting Efficacy Data The approval was based on findings from...
Glasdegib in Older Patients With AML or Those With Comorbidities
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Late in 2018, the Hedgehog pathway inhibitor glasdegib wa...
Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
Matthew Stenger
On September 17, 2019, apalutamide was approved for the treatment of patients with metastatic castration-sensitive prostate cancer.1,2 Supporting Efficacy Data The approval is based on overall survival and radiographic progression-free survival findings in the phase III double-blind TITAN trial.2,...
Elotuzumab in Combination Therapy for Previously Treated Multiple Myeloma
Matthew Stenger
In late 2018, elotuzumab was approved for use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 Supporting Efficacy Data Approval was base...
Trifluridine/Tipiracil in Recurrent, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Matthew Stenger
Early in 2019, trifluridine/tipiracil tablets were approved for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine; a platinum; either a taxane or irinot...
Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia
Matthew Stenger
In late 2018, calaspargase pegol-mknl, an asparagine-specific enzyme, was approved for use as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.1,2 The new product provides for a longer interval ...
Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Matthew Stenger
On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov id...
Daratumumab Combination Therapy for Patients With Multiple Myeloma Who Are Eligible for Transplantation
The ASCO Post Staff
On September 26, 2019, daratumu-mab (Darzalex) was approved in combination with bortezomib, thalidomide, and dexamethasone for the treatment of multiple myeloma in newly diagnosed adult patients eligible for autologous stem cell transplantation (ASCT).1,2 Supporting Efficacy Data Approval was base...
Pembrolizumab/Lenvatinib in Advanced Endometrial Carcinoma Without Microsatellite Instability–High or Mismatch Repair–Deficient Disease
Matthew Stenger
On September 17, 2019, the combination of pembrolizumab plus lenvatinib was granted accelerated approval for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) and who have disease progression followin...
Fedratinib for Myelofibrosis
Matthew Stenger
On August 16, 2019, fedratinib was approved for the treatment of adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1,2 Supporting Efficacy Data The approval was based on findings from the phase III double-blind JAK...
Entrectinib for NTRK-Positive Solid Tumors and ROS1-Positive Lung Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 15, 2019, the oral TRK, ROS1, and ALK kinase in...
Biosimilar to Trastuzumab in HER2-Overexpressing Breast, Metastatic Breast, and Metastatic Gastric Cancers
Matthew Stenger
Early in 2019, trastuzumab-dttb was approved as a biosimilar to standard trastuzumab for treatment of HER2-expressing breast cancer in the adjuvant setting, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior tre...
Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer
Matthew Stenger
EARLIER THIS YEAR, atezolizumab was granted accelerated approval in combination with nab-paclitaxel in the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express programmed cell death ligand 1 (PD-L1–stained tumor-infiltrating immune...
Adjuvant Treatment With Ado-trastuzumab Emtansine in HER2-Positive Early Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Earlier this year, ado-trastuzumab emtansine (T-DM1) was ...
Ramucirumab in Hepatocellular Carcinoma
Matthew Stenger
Earlier this year, ramucirumab was approved as a single agent for hepatocellular carcinoma in patients who have an alpha-fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib.1,2 Supporting Efficacy Data Approval was based on findings in the double-blind phase III REA...
Avelumab Plus Axitinib in Advanced Renal Cell Carcinoma
Matthew Stenger
Earlier this year, avelumab was approved for use in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III -JAVELIN Renal 101 trial (ClinicalTrials.gov identifier ...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
Matthew Stenger
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov id...
Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation
Matthew Stenger
On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase I...
Pembrolizumab in First-Line Treatment of Head/Neck Squamous Cell Carcinoma
Matthew Stenger
On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent fo...
Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10
Matthew Stenger
On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug Adm...
Alpelisib for PIK3CA-Mutated Advanced Breast Cancer
Matthew Stenger
On May 24, 2019, alpelisib was approved for use in combination with fulvestrant for postmenopausal women, and men, with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, as detected by a U.S. Food and Drug Administration (FDA)-approved test following dise...
Combined Use of Identification Methods for Dense Breasts and Discussion of Supplemental Imaging
Matthew Stenger
In a study reported in JAMA Internal Medicine, Karla Kerlikowske, MD, and colleagues found that the combined use of Breast Imaging Reporting and Data System (BI-RADS) breast density and Breast Cancer Surveillance Consortium (BCSC)-defined risk for breast cancer may be an effective way of identifyin...
Circulating Tumor DNA and Relapse in Early-Stage Breast Cancer
Matthew Stenger
In a study reported in JAMA Oncology, Nicholas C. Turner, PhD, and colleagues found that detection of circulating tumor DNA (ctDNA) during follow-up after initial treatment for early breast cancer was associated with a high risk of relapse. Detection at diagnosis was also associated with poorer rela...
Selinexor in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 3, 2019, the oral nuclear export i...
Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On July 30, 2019, darolutamide was approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1,2 Approval was based on findings in the double-blind phase III ARAMIS trial (ClinicalTrials.gov identifier NCT02200614), in which 1,509 patients were randomly assigned...
Atezolizumab Plus Chemotherapy and Bevacizumab in First-Line Treatment of Metastatic Lung Cancer
Matthew Stenger
In late 2018, atezolizumab was approved for use in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberration.1,2 Supporting Efficacy Data Approval wa...
Pexidartinib for Tenosynovial Giant Cell Tumor
Matthew Stenger
On August 2, the oral colony-stimulating factor 1 receptor inhibitor pexidartinib was approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.1,2 It is the first dr...
Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer
Matthew Stenger
On March 18, 2019, atezolizumab was approved for use in combination with carboplatin and etoposide in the first-line treatment of adult patients with extensive-stage small cell lung cance (SCLC).1,2 Supporting Efficacy Data Approval was based on findings in the phase III double-blind IMpower133 tr...
Pembrolizumab in Metastatic Small Cell Lung Cancer
Matthew Stenger
On June 17, 2019, pembrolizumab was granted accelerated approval for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.1,2 Supporting Efficacy Data Approval was based...
Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Matthew Stenger
On June 10, 2019, the CD79b-directed antibody-drug conjugate polatuzumab vedotin-piiq was granted accelerated approval for use in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after...
Pembrolizumab for Advanced Merkel Cell Carcinoma
Matthew Stenger
Late in 2018, pembrolizumab was granted accelerated approval in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1,2 Supporting Efficacy Data Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known ...
Brentuximab Vedotin in Untreated Systemic Anaplastic Large-Cell Lymphoma and CD30-Expressing Peripheral T-Cell Lymphomas
Matthew Stenger
On November 16, 2018, brentuximab vedotin was approved for use in combination with chemotherapy for previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL–not otherwise specified...
Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
Matthew Stenger
In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Early in 2019, ibrutinib was approved for ...
Erdafitinib for Metastatic Urothelial Carcinoma
Matthew Stenger
On April 12, 2019, erdafitinib was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, when the disease has progressed during or following platinum-containing che...
Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer
Matthew Stenger
ON DECEMBER 14, 2018, trastuzumab-pkrb (Herzuma) was approved as a biosimilar to trastuzumab for patients with HER2-overexpressing breast cancer.1 Trastuzumab-pkrb is indicated for adjuvant treatment of HER2-overexpressing breast cancer and metastatic HER2-overexpressing breast cancer.2 Health-care ...
Cabozantinib for Hepatocellular Carcinoma Previously Treated With Sorafenib
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 14, 2019, cabozantinib was approved for the tr...
Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 30, 2018, pembrolizumab in combination with ca...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 26, 2018, larotrectinib (Vitrakvi) was grante...
Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
Matthew Stenger
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma
Matthew Stenger
ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial (ClinicalTrial...
Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 24, 2018, duvelisib (Copiktra) was granted r...
Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia
Matthew Stenger
ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting Eff...
Lenvatinib in Unresectable Hepatocellular Carcinoma
Matthew Stenger
On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously ...
Talazoparib for Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
Matthew Stenger
On October 16, 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna) was approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.1,2 Patients must be selected for ther...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
Matthew Stenger
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kin...
Ibrutinib Plus Rituximab in Adult Patients With Waldenström’s Macroglobulinemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 27, 2018, ibrutinib (Imbruvica) was approved fo...
Dacomitinib for Metastatic EGFR-Mutant NSCLC
Matthew Stenger
On September 27, 2018, dacomitinib (Vizimpro) received approval for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by a test approved by the U.S...
Cemiplimab-rwlc for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
Matthew Stenger
On September 28, 2018, cemiplimab-rwlc (Libtayo) was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.1 Supporting Efficacy Data Approval ...
Iobenguane I-131 for Advanced Pheochromocytoma or Paraganglioma
Matthew Stenger
ON JULY 30, 2018, the radiotherapeutic agent iobenguane I-131 (Azedra) was approved for the treatment of adult and pediatric patients (aged ≥ 12 years) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therap...
Nivolumab for Third-Line Treatment of Metastatic Small Cell Lung Cancer
Matthew Stenger
ON AUGUST 16, 2018, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression after platinum-based chemotherapy and at least one other line of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on fin...
Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy
Matthew Stenger
On June 8, 2018, venetoclax (Venclexta) was granted regular approval for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED o...
Nilotinib for Pediatric Patients With Philadelphia Chromosome–Positive CML in Chronic Phase
Matthew Stenger
Earlier in 2018, nilotinib (Tasigna) was approved for the treatment of pediatric patients aged ≥ 1 year with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CML-CP) or Philadelphia chromosome–positive CML-CP resistant or intolerant to prior tyrosine kinase...
Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 16, 2018, nivolumab (Opdivo) and ipilimumab (Yer...
Everolimus Tablets for Oral Suspension for Tuberous Sclerosis Complex–Associated Partial-Onset Seizures
Matthew Stenger
On April 10, 2018, the U.S. Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz) for the adjunctive treatment of adult and pediatric patients aged ≥ 2 years with tuberous sclerosis complex–associated partial-onset seizures.1,2 Tuberous sclerosis complex is ...
Osimertinib in First-Line Treatment of EGFR-Mutant Metastatic NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. In April 2018, osimertinib (Tagrisso) was approved for th...
Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
Matthew Stenger
On August 8, 2018, the CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody mogamulizumab-kpkc (Poteligeo) was approved for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.1,2 Supporting Efficacy Data The current...
Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Matthew Stenger
IN APRIL 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib (Rubraca) was granted approval for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 T...
Ipilimumab in Combination With Nivolumab for MSI-H or dMMR Metastatic Colorectal Cancer
Matthew Stenger
On July 10, 2018, ipilimumab (Yervoy) was granted accelerated approval for use in combination with nivolumab (Opdivo) for the treatment of patients at least 12 years of age with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cancer progressing after...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 18, 2018, the indication for ribociclib (Kisqali)...
Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 13, 2018, pembrolizumab (Keytruda) was granted ac...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
Matthew Stenger
In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S. Foo...
Abiraterone Acetate Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
Matthew Stenger
IN EARLY 2018, abiraterone acetate tablets (Yonsa, Zytiga) in combination with prednisone was approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS BASED on findings from the phase III LATITUDE trial, in which 1,199 pati...
Pertuzumab in Adjuvant Treatment of HER2-Positive Breast Cancer
Matthew Stenger
AT THE END OF 2017, pertuzumab (Perjeta) was granted regular approval for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2- positive early breast cancer at high risk of recurrence.1,2 Supporting Efficacy Data APPROVAL WAS BASED on findi...
Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 13, 2018, enzalutamide (Xtandi) was approved for ...
Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma
Matthew Stenger
In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on t...
Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
Matthew Stenger
ON JULY 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.1,2 The FDA simu...
Blinatumomab in Adult and Pediatric Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Matthew Stenger
EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS ...
Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. This past June, encorafenib (Braftovi) and binimetinib (M...
Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Matthew Stenger
Early in 2018, abemaciclib (Verzenio) in combination with an aromatase inhibitor was approved as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.1,2 Supporting Efficacy Data Approval was based on findings i...
Durvalumab After Chemoradiation in Unresectable Stage III NSCLC
Matthew Stenger
Early in 2018, durvalumab (Imfinzi) was approved for the treatment of unresectable stage III non–small cell lung cancer (NSCLC) that has not progressed following concurrent platinum-based chemotherapy and radiation therapy.1,2 Supporting Efficacy Data Approval was based on a planned interim analys...
Pegfilgrastim-jmdb as Biosimilar to Pegfilgrastim to Decrease Risk of Infection During Cancer Treatment
Matthew Stenger
On June 4, 2018, pegfilgrastim-jmdb (Fulphila) was approved as a biosimilar to pegfilgrastim (Neulasta) to decrease infection risk in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy associated with a significant incidence of febrile neutropenia.1,2 Approval Basis Approval w...
Abiraterone Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
Matthew Stenger
EARLY IN 2018, abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS based on the findings of the phase III LATITUDE trial, in which 1,199 patients...
Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
Matthew Stenger
EARLY IN 2018, olaparib tablets (Lynparza) were granted regular approval for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.1,2 O...
Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer
Matthew Stenger
ON JUNE 13, 2018, bevacizumab (Avastin) was granted approval for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection1,2. The U....
Circulating Tumor Cells and Adjuvant Radiotherapy in Early Breast Cancer
Matthew Stenger and compiled by Sarah Jackson
In a study reported in JAMA Oncology by Chelain R. Goodman, MD, PhD, of the Department of Radiation Oncology at Northwestern University Feinberg School of Medicine, and colleagues, adjuvant radiotherapy was associated with better outcome in patients with early breast cancer who had detectable circ...
Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Earlier this year, apalutamide (Erleada) was approved for...
Dabrafenib Plus Trametinib for Thyroid Cancer, Melanoma With BRAF Mutations
Matthew Stenger
On May 4, 2018, dabrafenib (Tafinlar) and trametinib (Mekinist) in combination was granted approval for treatment of patients with locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and no satisfactory locoregional treatment options.1-3 Dabrafenib is not indicated for ...
Tisagenlecleucel for Adults With Relapsed or Refractory Large B-Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2018, tisagenlecleucel (Kymriah), a CD19-direct...
Brentuximab Vedotin in Previously Untreated Stage III or IV Classical Hodgkin Lymphoma
Matthew Stenger
On March 20, 2018, brentuximab vedotin (Adcetris) was approved for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase III ECHEL...
Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR Mutations
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 12, 2018, afatinib (Gilotrif) was approved fo...
Nilotinib Label Updated to Provide Treatment Discontinuation Recommendations for CML With Sustained Molecular Response
Matthew Stenger
On December 22, 2017, the product label for nilotinib (Tasigna) was updated to include information on nilotinib discontinuation, postdiscontinuation monitoring, and guidance for treatment reinitiation in patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) who have achi...
Nivolumab in Adjuvant Treatment of Melanoma
Matthew Stenger
On December 20, 2017, nivolumab (Opdivo) was granted regular approval for adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.1,2 Nivolumab was previously approved for the treatment of patients with unresectable or meta...
Venetoclax in Chronic Lymphocytic Leukemia Progressing After Ibrutinib
Matthew Stenger
An interim analysis of a phase II trial reported by Jones et al in The Lancet Oncology indicates that venetoclax (Venclexta) produces a response in a high proportion of patients with chronic lymphocytic leukemia (CLL) progressing on or after ibrutinib (Imbruvica) treatment. John C. Byrd, MD, of The ...
Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer
Matthew Stenger
In a phase II trial reported in JAMA Oncology by Debra L. Richardson, MD, of Stephenson Cancer Center, Oklahoma University Health Science Center, and colleagues, the addition of pazopanib (Votrient) to paclitaxel did not improve progression-free survival among women with persistent or recurrent ov...
Bosutinib in Newly Diagnosed Chronic-Phase Philadelphia Chromosome–Positive Chronic Myeloid Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 19, 2017, bosutinib (Bosulif) was granted acc...
Cabozantinib in Advanced Renal Cell Carcinoma
Matthew Stenger
ON DECEMBER 19, 2017, cabozantinib (Cabometyx) was granted regular approval for the treatment of advanced renal cell carcinoma.1,2 Cabozantinib was initially granted approval in 2016 for the treatment of patients with advanced renal cell carcinoma who had received prior antiangiogenic therapy. The c...
Bevacizumab in Recurrent Glioblastoma
Matthew Stenger
On December 5, 2017, bevacizumab (Avastin) was granted regular approval for the treatment of recurrent glioblastoma in adults.1 Bevacizumab was granted accelerated approval in May 2009 for use in treating patients with glioblastoma who had disease progression on prior therapy. Supporting Efficacy D...
Lutetium Lu-177 Dotatate in Gastroenteropancreatic Neuroendocrine Tumors
Matthew Stenger
On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting Effica...
Blinatumomab in Relapsed or Refractory B-Cell Precursor ALL
Matthew Stenger
On July 11, 2017, blinatumomab (Blincyto) was approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.1,2 Blinatumomab received accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative rel...
Enasidenib in IDH2-Mutant Relapsed or Refractory Acute Myeloid Leukemia
Matthew Stenger
On August 1, 2017, the IDH2 inhibitor enasidenib (Idhifa) was granted regular approval for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test...
Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA
Matthew Stenger
On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no s...
Daratumumab in Previously Treated Multiple Myeloma
Matthew Stenger
On June 16, 2017, daratumumab -(Darzalex) was approved for use in combination with pomalidomide (Pomalyst) and dexamethasone for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.1,2 Supporting ...
Trastuzumab-dkst Approved as Biosimilar to Trastuzumab
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 1, 2017, trastuzumab-dkst (Ogivri) was approv...
Ceritinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On May 26, 2017, ceritinib (Zykadia) was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration–approved test.1,2 In 2014, the drug received...
Pembrolizumab in Advanced Urothelial Carcinoma
Matthew Stenger
On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-contai...
Plasma Epstein-Barr Virus DNA Screening for Nasopharyngeal Cancer
Matthew Stenger
In a Hong Kong study reported in The New England Journal of Medicine, K.C. Allen Chan, MBBS, PhD, MRCP, FRCPA, FHKCPath, FHMAM, of The Chinese University of Hong Kong, Department of Chemical Pathology, and colleagues found that screening for circulating cell-free Epstein-Barr virus (EBV) DNA is us...
Obinutuzumab in Previously Untreated Follicular Lymphoma
Matthew Stenger
On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular l...
Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma
Matthew Stenger
On November 16, 2017, sunitinib malate (Sutent) was approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.1,2 Supporting Efficacy Data Approval was based on the findings of the double-blind phase III S-TRAC trial in which 615 pat...
Lower Dose of Cabazitaxel in Prostate Cancer
Matthew Stenger
On September 14, 2017, the microtubule inhibitor cabazitaxel (Jevtana) was approved at the lower dose of 20 mg/m2 every 3 weeks in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.1,2 Cab...
Fulvestrant Monotherapy for Postmenopausal Women With Advanced Breast Cancer
Matthew Stenger
On August 28, 2017, fulvestrant (Faslodex) was approved at 500 mg as monotherapy for expanded use in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who have not received previous endocrine therapy.1 Supporting Efficacy Data Approval was based on improved ...
Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia
Matthew Stenger
On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination w...
Alectinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was ba...
Brentuximab Vedotin for Adult Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
Matthew Stenger
On November 9, 2017, brentuximab vedotin (Adcetris) received regular approval for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.1,2 Supporting Efficacy Data Approval was based on ...
Vemurafenib in Erdheim-Chester Disease
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 6, 2017, vemurafenib (Zelboraf) was granted r...
Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia
Matthew Stenger
On November 9, 2017, dasatinib (Sprycel) was granted regular approval for treatment of pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase.1,2 Supporting Efficacy Data Approval was based on findings among 97 pediatric patients with chronic-phase...
Intravenous Rolapitant for Chemotherapy-Induced Delayed Nausea and Vomiting
Matthew Stenger
On October 25, 2017, intravenous (IV) rolapitant (Varubi) was approved for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including but not limited to highly eme...
Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
Matthew Stenger
On August 17, 2017, olaparib -(Lynparza) in tablet form was granted regular approval for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 Olaparib tablets...
Acalabrutinib in Previously Treated Mantle Cell Lymphoma
Matthew Stenger
On October 31, 2017, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) was granted accelerated approval for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.1,2 Supporting Efficacy Data Approval was based on objective response ...
Ibrutinib in Chronic Graft-vs-Host Disease
Matthew Stenger
On August 2, 2017, ibrutinib (Imbruvica) was approved for treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1,2 This is the first U.S. Food and Drug Administration (FDA)-approved therapy for treatment of chronic graft-vs-host diseas...
Liposome-Encapsulated Daunorubicin and Cytarabine for AML Subtypes
Matthew Stenger
On August 3, 2017, a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) was approved for treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.1,2 This is the first U.S. Food and Drug Administration–app...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 18, 2017, the chimeric antigen receptor (CAR) ...
Copanlisib in Relapsed Follicular Lymphoma
Matthew Stenger
On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phas...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
Matthew Stenger
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocr...
Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
Matthew Stenger
On July 17, 2017, neratinib (Nerlynx) a dual inhibitor of HER2 and epidermal growth factor receptor (EGFR), was approved for extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab (Herceptin)-based therapy.1,2 Supporting Effi...
Dabrafenib and Trametinib in BRAF V600E–Mutant Metastatic NSCLC
Matthew Stenger
On June 22, 2017, regular approvals were granted to dabrafenib (Tafinlar) and trametinib (Mekinist) given in combination for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test.1-...
Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer
Matthew Stenger
On April 28, 2017, brigatinib (Alunbrig) was granted accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).1,2 Supporting Efficacy ...
Pembrolizumab in Advanced Gastric Cancer
Matthew Stenger
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug Adminis...
Nivolumab in Hepatocellular Carcinoma Previously Treated With Sorafenib
Matthew Stenger
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
Matthew Stenger
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine, oxaliplati...
Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 22, 2017, the combination of rituximab (Rituxan) ...
Durvalumab in Advanced Urothelial Carcinoma Progressing After Platinum Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2017, durvalumab (Imfinzi) was granted accelera...
Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 9, 2017, avelumab (Bavencio) was granted accelerat...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
Matthew Stenger
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL tri...
Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia
Matthew Stenger
On August 30, 2017, tisagenlecleucel (Kymriah) was granted regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1,2 Tisagenlecleucel is the first chimeric antigen receptor (CAR) T...
Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib
Matthew Stenger
On April 27, 2017, the indications for regorafenib (Stivarga) were expanded to include treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data The new approval was based on the finding of improved overall survival w...
Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2017, the programmed cell death ligand 1 (PD-L1) inhib...
Pembrolizumab in Classical Hodgkin Lymphoma
Matthew Stenger
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on dur...
Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis
Matthew Stenger
ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin i...
Combination Therapy With Pembrolizumab in Metastatic Nonsquamous NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 10, 2017, pembrolizumab (Keytruda) was granted accelerated ...
Niraparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Matthew Stenger
On March 27, 2017, the oral poly ADP-ribose polymerase (PARP) inhibitor niraparib (Zejula) was approved for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 Su...
Palbociclib Combined With Aromatase Inhibitor in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Matthew Stenger
On March 31, 2017, palbociclib (Ibrance) was granted regular approval for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.1,2 Palbociclib received accel...
Osimertinib in Metastatic EGFR T790M–Mutant NSCLC After EGFR Inhibitor Therapy
Matthew Stenger
On March 30, 2017, osimertinib (Tagrisso) was granted regular approval for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M–mutant non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test, who have progressed ...
Avelumab in Merkel Cell Carcinoma
Matthew Stenger
On March 23, 2017, avelumab (Bavencio) was granted accelerated approval for treatment of patients aged ≥ 12 years with metastatic Merkel cell carcinoma. Avelumab is the first U.S. Food and Drug Administration–approved product to treat this disease.1,2 Supporting Efficacy Data Approval was based ...
Lenalidomide as Maintenance Therapy in Multiple Myeloma After Autologous Stem Cell Transplantation
Matthew Stenger
On February 22, lenalidomide (Revlimid) was approved as maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplantation.1,2 The drug was previously approved to treat multiple myeloma (in combination with dexamethasone), anemia caused by del(5q)-r...
Nivolumab in Urothelial Carcinoma After Platinum Therapy
Matthew Stenger
On February 2, 2017, nivolumab (Opdivo) was granted accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant ...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Matthew Stenger
On March 13, the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) was approved for use in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast...
Ibrutinib in Marginal Zone Lymphoma
Matthew Stenger
On January 19, ibrutinib (Imbruvica) was granted accelerated approved for treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20–based therapy.1 Supporting Efficacy Data Approval was based on overall response rate in a single...
Rucaparib in Previously Treated BRCA Mutation–Associated Ovarian Cancer
Matthew Stenger
On December 19, 2016, rucaparib (Rubraca) was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) advanced ovarian cancer who have received two or more prior chemotherapy regimens.1,2 The U.S. Food and Drug Administration (FDA)...
Daratumumab in Previously Treated Multiple Myeloma
Matthew Stenger
On November 21, 2016, daratumumab (Darzalex) was approved for use in combination with lenalidomide (Revlimid) and dexamethasone or with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.1,2 The drug was initially...
Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Matthew Stenger
On November 10, 2016, nivolumab (Opdivo) was approved for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.1,2 Supporting Efficacy Data Approval was based on the finding of an overall survival advantage...
Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration (FDA)-appro...
Atezolizumab in Previously Treated Metastatic NSCLC
Matthew Stenger
On October 18, 2016, the anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab (Tecentriq) was approved for the treatment of metastatic non–small cell lung cancer (NSCLC) progressing during or following platinum-containing chemotherapy.1,2 Patients with epidermal growth factor receptor...
Modified Indication for Erlotinib in Advanced Non–Small Cell Lung Cancer
Matthew Stenger
On October 18, 2016, the indication for erlotinib (Tarceva) in the treatment of non–small cell lung cancer (NSCLC) was modified to limit use to patients with tumors with specific epidermal growth factor receptor (EGFR) mutations in maintenance or second- or greater-line treatment; these mutations ...
Olaratumab in Soft-Tissue Sarcoma
Matthew Stenger
On October 19, 2016, the platelet-derived growth factor receptor alpha (PDGFR-α)-blocking antibody olaratumab (Lartruvo) was granted accelerated approval in combination with doxorubicin for the treatment of soft-tissue sarcoma not amenable to curative treatment with radiotherapy or surgery and wit...
Modification of Dosage Regimen for Nivolumab in Renal Cell Carcinoma, Melanoma, and NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 13, 2016, the U.S. Food and Drug Administration modifi...
Use of Pembrolizumab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Therapy
Matthew Stenger
On August 5, 2016, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma and disease progression on or after platinum-containing chemotherapy.1,2 As a condition of the accelerated approval, Merck is r...
Nivolumab in Classical Hodgkin Lymphoma
Matthew Stenger
On May 17, 2016, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (Adcetris).1,2 Continued approval for...
PD-L1 Inhibitor Atezolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.On May 18, 2016, the PD-L1 (programmed cell death ligand 1) inhibitor...
Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 13, 2016, lenvatinib (Lenvima) was approved for use in combi...
Venetoclax for Previously Treated Chronic Lymphocytic Leukemia With 17p Deletion
Matthew Stenger
On April 11, 2016, venetoclax (Venclexta) was approved for treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by a U.S. Food and Drug Administration (FDA)-approved test, who have received at least one prior therapy.1,2 The accelerated approval was based o...
Cabozantinib in Advanced Renal Cell Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 25, 2016, a tablet formulation of cabozantinib (Cabometyx...
Relatives of Patients With Carcinoma of Unknown Primary at Increased Risk for This and Other Cancers
Relatives of patients with carcinoma of unknown primary are at increased risk of developing this type of cancer themselves and several other malignant neoplasms, including lung, pancreatic, and colon cancers; non-Hodgkin lymphoma; and myeloma, according to a study published in JAMA Oncology. “Some o...
Defibrotide Sodium for Hepatic Veno-occlusive Disease After HSCT
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On March 30, 2016, defibrotide sodium (Defitelio) was approved for ...
Crizotinib in ROS1-Positive Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On March 11, 2016, crizotinib (Xalkori) was approved for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ROS1 rearrangement–positive tumors.1,2 A U.S. Food and Drug Administration–approved test for the detection of ROS1 rearrangements in NSCLC is not currently availab...
Everolimus in Advanced Neuroendocrine Tumors
Matthew Stenger
On February 26, 2016, everolimus (Afinitor) was approved for treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced, or metastatic.1,2 The drug was previously approved for tr...
Palbociclib Combined With Fulvestrant in Advanced Breast Cancer Progressing After Endocrine Therapy
Matthew Stenger
On February 19, 2016, palbociclib (Ibrance) was approved for use in combination with fulvestrant (Faslodex) for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.1,2 In February 2015, palbociclib in combi...
Obinutuzumab in Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
On February 26, 2016, obinutuzumab (Gazyva) was approved for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for treatment of patients with follicular lymphoma who have relapsed after or are refractory to a rituximab (Rituxan)-containing regimen.1,2 Su...
Carfilzomib Plus Dexamethasone in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 21, 2016, carfilzomib (Kyprolis) was approved for use in...
Eribulin Mesylate in Advanced Liposarcoma Previously Treated With an Anthracycline
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 28, 2016, eribulin mesylate (Halaven) was approved for t...
Ofatumumab for Extended Treatment of Patients With Recurrent or Progressive Chronic Lymphocytic Leukemia
Matthew Stenger
On January 19, 2016, ofatumumab (Arzerra) was approved for extended treatment of patients in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).1,2 Ofatumumab was previously approved for treatment of untreated patients w...
Nivolumab Plus Ipilimumab in Unresectable or Metastatic Melanoma Regardless of BRAF Mutation Status
Matthew Stenger
On January 23, 2016, the indication for nivolumab (Opdivo) plus ipilimumab (Yervoy) in unresectable or metastatic melanoma was expanded through accelerated approval to include patients regardless of BRAF V600 mutation status.1 The combination was previously approved for treatment of patients with ...
Expanded Approval of Pembrolizumab in Unresectable or Metastatic Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 18, 2015, approval of the programmed cell death prot...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 11, 2015, alectinib (Alecensa) was granted accelerat...
Elotuzumab in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 30, 2015, elotuzumab (Empliciti) was approved for u...
Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 11, 2015, uridine triacetate (Vistogard) was approved...
Nivolumab in Advanced Renal Cell Carcinoma After Antiangiogenic Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 23, 2015, nivolumab (Opdivo) was approved for use in...
Nivolumab as Single-Agent Treatment for BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 24, 2015, nivolumab (Opdivo) was approved for use as...
Necitumumab in Metastatic Squamous Non–Small Cell Lung Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 24, 2015, necitumumab (Portrazza) was approved for us...
Cobimetinib in BRAF-Mutant Unresectable or Metastatic Melanoma in Combination With Vemurafenib
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs On November 10, 2015, the U.S. Food and Drug Administration approv...
Osimertinib for Metastatic EGFR T790M–Mutant Non–Small Cell Lung Cancer After EGFR Inhibitor Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 13, 2015, osimertinib (Tagrisso) was granted accelerate...
Daratumumab in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 16, 2015, daratumumab injection (Darzalex) was grant...
Ixazomib in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 20, 2015, ixazomib (Ninlaro) was approved by the U.S. F...
Ipilimumab in Adjuvant Treatment of Cutaneous Melanoma With Nodal Involvement
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 28, 2015, ipilimumab (Yervoy) was approved for adjuvan...
Talimogene Laherparepvec for Treatment of Unresectable Cutaneous, Subcutaneous, and Nodal Melanoma Lesions
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 27, 2015, talimogene laherparepvec (Imlygic) was appro...
Trabectedin in Unresectable or Metastatic Liposarcoma or Leiomyosarcoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 23, 2015, trabectedin (Yondelis) was approved for the ...
Irinotecan Liposome Injection Plus Fluorouracil/Leucovorin to Treat Patients With Metastatic Pancreatic Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 22, 2015, irinotecan liposome injection (Onivyde) giv...
Nivolumab in Metastatic NSCLC After Platinum Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 9, 2015, the anti–programmed cell death protein 1 (PD-...
Nivolumab in Combination With Ipilimumab in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 30, 2015, the U.S. Food and Drug Administration gran...
Pembrolizumab in Previously Treated PD-L1–Positive Metastatic NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 2, 2015, the U.S. Food and Drug Administration granted...
Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 2, 2015, rolapitant (Varubi) was approved for use in c...
Brentuximab Vedotin for Consolidation Therapy in High-Risk Hodgkin Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 17, 2015, brentuximab vedotin (Adcetris) was approved ...
Gefitinib in EGFR-Mutant Metastatic NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 13, 2015, gefitinib (Iressa) was approved for first-line ...
Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 24, 2015, carfilzomib (Kyprolis) was approved for use in...
Sonidegib in Basal Cell Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 24, 2015, sonidegib (Odomzo) was approved for treatment o...
Ramucirumab With FOLFIRI in Metastatic Colorectal Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 24, the monoclonal antibody ramucirumab (Cyramza) was app...
Dinutuximab in Pediatric High-Risk Neuroblastoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On March 10, 2015, the chimeric monoclonal antibody dinutuximab ...
Biosimilar Filgrastim-sndz in Filgrastim Indications
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On March 6, 2015, the granulocyte colony-stimulating factor filg...
Nivolumab in Metastatic Squamous Non–Small Cell Lung Cancer After Platinum Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On March 4, 2015, the anti–programmed cell death protein 1 (PD-1...
Lenalidomide in Combination With Dexamethasone in Newly Diagnosed Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 18, 2015, the indication for lenalidomide (Revlimid)...
Panobinostat in Combination With Bortezomib‑Dexamethasone in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 23, 2015, panobinostat (Farydak) was granted acceler...
Lenvatinib in Advanced Radioiodine-Refractory Differentiated Thyroid Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 13, 2015, lenvatinib (Lenvima) was approved for the ...
Palbociclib as Initial Endocrine-Based Therapy in Postmenopausal Women With Metastatic Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 3, 2015, palbociclib (Ibrance) was granted accelerat...
Ibrutinib for Waldenström’s Macroglobulinemia
The ASCO Post
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 29, 2015, the U.S. Food and Drug Administration (FDA)...
Blinatumomab in Philadelphia Chromosome–Negative Relapsed/Refractory B-Cell Precursor ALL
The ASCO Post
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 3, 2014, blinatumomab (Blincyto) was granted accelerate...
Ruxolitinib for Polycythemia Vera
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 4, 2014, ruxolitinib (Jakafi) was approved for the trea...
Ramucirumab in Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. In December 12, 2014, ramucirumab (Cyramza) was approved for use in...
Anti–PD-1 Antibody Nivolumab in Previously Treated Unresectable or Metastatic Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 22, 2014, the anti–PD-1 (programmed cell death prote...
Lanreotide in Gastroenteropancreatic Neuroendocrine Tumors
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 16, 2014, lanreotide (Somatuline depot injection) wa...
Gardasil 9 Adds Protection Against Cancer Caused by Additional Human Papillomavirus Types
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 10, 2014, Gardasil 9 (human papillomavirus 9-valent ...
Olaparib for BRCA-Mutated Previously Treated Advanced Ovarian Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 19, 2014, olaparib (Lynparza) was granted accelerated a...
Bevacizumab Plus Chemotherapy in Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The ASCO Post
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 14, 2014, bevacizumab (Avastin) in combination with pac...
Bortezomib in Previously Untreated Mantle Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 9, 2014, bortezomib (Velcade) was granted approval fo...
Fixed-Combination Netupitant/Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 10, 2014, oral fixed-combination netupitant and palon...
Ramucirumab in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 5, 2014, ramucirumab (Cyramza) was approved for use ...
First Approval of PD-1 Inhibitor: Pembrolizumab in Unresectable or Metastatic Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 4, 2014, pembrolizumab (Keytruda) was granted accel...
Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 10, 2014, the androgen receptor inhibitor enzalutam...
Bortezomib Retreatment in Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 8, 2014, the approved use of bortezomib (Velcade) in mult...
Bevacizumab in Persistent, Recurrent, or Metastatic Cervical Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 14, 2014, bevacizumab (Avastin) was approved for the t...
Idelalisib for Relapsed CLL in Combination With Rituximab and for Relapsed Follicular Lymphoma or Small Lymphocytic Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 23, 2014, idelalisib (Zydelig) was approved for use in ...
Ibrutinib in Previously Treated CLL and CLL With 17p Deletion
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 28, 2014, the approved use of ibrutinib (Imbruvica) in p...
Belinostat for Relapsed/Refractory Peripheral T-Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 3, 2014, belinostat (Beleodaq) was granted accelerated ...
Panitumumab Plus FOLFOX for KRAS Wild-Type Metastatic Colorectal Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Panitumumab (Vectibix) was recently approved by the U.S. Food and D...
Siltuximab for Multicentric Castleman’s Disease
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 23, 2014, the anti–interleukin (IL)-6 monoclonal antibody ...
Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 28, 2014, an oral suspension of mercaptopurine (Purixan...
Ceritinib in ALK-Positive Metastatic NSCLC Patients With Progression on or Intolerance to Crizotinib
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 29, 2014, ceritinib (Zykadia) was granted accelerated appr...
Ofatumumab Plus Chlorambucil for Previously Untreated CLL in Patients Not Treatable With Fludarabine-Based Regimens
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2014, ofatumumab (Arzerra) received regular approval f...
Ramucirumab for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Matthew Stenger
On April 21, 2014, ramucirumab (Cyramza) was approved for use as a single agent in the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy...
Ibrutinib for Previously Treated Chronic Lymphocytic Leukemia
Matthew Stenger
On February 12, 2014, ibrutinib (Imbruvica) was granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1,2 Ibrutinib previously received accelerated approval for the treatment of patients with mantle cell lympho...
Trametinib and Dabrafenib in Combination for Unresectable or Metastatic Melanoma With BRAF V600E or V600K Mutations
Matthew Stenger
On January 9, 2014, the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) was granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2...
City of Hope Receives $10 Million Gift to Launch Lymphoma Research and Treatment Center
The ASCO Post
A $10 million gift from Internet publishing entrepreneurs and philanthropists Emmet and Toni Stephenson and their daughter Tessa Stephenson Brand will fund the creation of the Toni Stephenson Lymphoma Center at City of Hope, Duarte, California, the cornerstone of the institution’s new Hematologic Ma...
Radiation Oncology Institute Awards $200,000 Grant to Christopher Slatore, MD
The ASCO Post
The Radiation Oncology Institute (ROI) has named Christopher G. Slatore, MD, recipient of a $200,000 award, distributed over 2 years, for a project to examine the comparative value of radiation therapy and patient outcomes among patients with lung cancer. Dr. Slatore is Assistant Professor in the Di...
Ongoing NCI-Funded Clinical Trials Actively Recruiting Patients With Hematologic Cancers: Multiple Myeloma
Jo Cavallo
Study Type: Non-Randomized Phase I/Interventional Study Title: Multicenter Phase I Study of Th1/Tc1 Immunotherapy Following Autologous Hematopoietic Progenitor Cell Transplantation in High-Risk Multiple Myeloma Study Sponsor and Collaborators: National Cancer Institute; Hackensack University Medic...
Sorafenib in Differentiated Thyroid Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. New Indication On November 22, 2013, sorafenib (Nexavar) was appro...
Ibrutinib in Previously Treated Mantle Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On November 13, 2013, ibrutinib (Imbruvica) was granted...
Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On November 1, 2013, obinutuzumab (Gazyva) was approved...
Pertuzumab in Neoadjuvant Treatment of HER2-Positive Early Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On September 30, 2013, pertuzumab injection (Perjeta) w...
Nab-Paclitaxel in Metastatic Pancreas Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On September 6, paclitaxel protein-bound particles [alb...
Afatinib as First-line Treatment for Metastatic NSCLC with EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On July 12, 2013, afatinib (Gilotrif) was approved for ...
Lenalidomide in Relapsed/Progressed Mantle Cell Lymphoma after Two Prior Therapies Including Bortezomib
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On June 5, 2013, lenalidomide (Revlimid) was approved f...
Denosumab in Adults and Skeletally Mature Adolescents with Giant Cell Tumor of Bone
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On June 13, 2013, denosumab (Xgeva) was approved for th...
Radium-223 Dichloride for Castration-resistant Prostate Cancer with Symptomatic Bone Metastases
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 15, 2013, radium Ra 223 dichloride (Xofigo) was ...
Erlotinib in First-line Treatment of Metastatic NSCLC with EGFR Exon 19 Deletion or Exon 21 (L858R) Substitution
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 14, 2013, erlotinib (Tarceva) was approved for...
Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, dabrafenib (Tafinlar) was approved fo...
Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, trametinib (Mekinist) was approved by ...
Ado-Trastuzumab Emtansine in Metastatic Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On February 22, 2013, ado-trastuzumab emtansine (Kadcy...
Pomalidomide in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On February 8, 2013, the immunomodulatory agent pomalid...
Bevacizumab plus Chemotherapy after Progression of Metastatic Colorectal Cancer on First-line Therapy Including Bevacizumab
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On January 23, 2013, bevacizumab (Avastin) was approved...
Abiraterone in Patients with Metastatic Castration-resistant Prostate Cancer and No Prior Chemotherapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On December 10, 2012, abiraterone acetate (Zytiga) rece...
Ponatinib in Chronic Myeloid Leukemia and Philadelphia Chromosome–positive Acute Lymphoblastic Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On December 14, 2012, ponatinib (Iclusig) was granted a...
Cabozantinib in Metastatic Medullary Thyroid Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On November 29, 2012, cabozantinib (Cometriq) was appr...
Omacetaxine for Chronic or Accelerated Phase CML Patients with Resistance/Intolerance to Tyrosine Kinase Inhibitors
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On October 26, 2012, the FDA granted accelerated approv...
Liposomal Vincristine for Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 2012, vinCRIStine sulfate LIPOSOME injection ...
SIDEBAR: REPORT ADVERSE EVENTS
Matthew Stenger
Health-care professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mailing the postage-paid addre...
Revised Everolimus Dosing and New Safety/Efficacy Data for Approval in Subependymal Giant Cell Astrocytoma
Matthew Stenger
On August 29, 2012, everolimus in a tablet for oral suspension form (Afinitor Disperz) was given accelerated approval for the treatment of pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but canno...
Regorafenib, Multikinase Inhibitor, for Previously Treated Metastatic Colorectal Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On September 27, 2012, regorafenib (Stivarga) was appro...
Albumin-bound Paclitaxel in First-line Treatment of Advanced NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On October 11, 2012, paclitaxel protein-bound particles...
Ruxolitinib: Novel Drug for Myelofibrosis
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In November 2011, ruxolitinib (Jakafi) was approved for...
Vismodegib: Novel Agent for Treating Advanced Basal Cell Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, vismodegib (Erivedge) was approved for...
Bosutinib in Chronic Myelogenous Leukemia Patients with Resistance or Intolerance of Prior Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In September 4, 2012, bosutinib (Bosulif) was approved ...
Enzalutamide for Metastatic Castrate-resistant Prostate Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 31, enzalutamide (Xtandi) was approved for th...
New Indication for Cetuximab plus FOLFIRI to Treat EGFR-positive, Wild-type KRAS Metastatic Colorectal Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In July 2012, cetuximab (Erbitux) was approved for use ...
Ziv-aflibercept with FOLFIRI in Metastatic Colorectal Cancer
Matthew Stenger
In August 2012, the antiangiogenic agent ziv-aflibercept (Zaltrap) was approved for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer resistant to or progressing after an oxaliplatin-containing regimen.1,2 Approval was based on ...
Carfilzomib: New Drug with Accelerated Approval for Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In July 2012, carfilzomib (Kyprolis) was granted accele...
Pertuzumab: New Drug for HER2-positive Metastatic Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In June 2012, pertuzumab (Perjeta) was approved for use...
Pazopanib: New Drug for Advanced Soft-tissue Sarcoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In April 2012, pazopanib (Votrient) was approved for th...
Everolimus: New Indication in Renal Angiomyolipoma Associated with Tuberous Sclerosis Complex
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In April 2012, the kinase inhibitor everolimus (Afinito...
Newest Indication for Rituximab as Maintenance Treatment in Non‑Hodgkin Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication The CD20-directed monoclonal antibody rituximab (Rituxa...
What You Need to Know About Glucarpidase Injection for Toxic Methotrexate Levels in Renal Impairment
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, glucarpidase injection (Voraxaze) was ...
Vandetanib: New Drug for Unresectable Medullary Thyroid Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication The oral kinase inhibitor vandetanib (Caprelsa) was rec...
Using Imatinib for Adjuvant Treatment after Resection of Kit (CD117)-positive Gastrointestinal Stromal Tumors
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, imatinib mesylate (Gleevec) was grante...
Erwinia chrysanthemi Asparaginase for Acute Lymphoblastic Leukemia in Patients with Hypersensitivity to E coli–derived Asparaginase
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Erwinia chrysanthemi asparaginase (Erwinaze) was recent...
What You Need to Know About Axitinib, New Agent for Treating Advanced Renal Cell Carcinoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, the second-generation vascular endothe...
What You Should Know about Peginterferon Alfa-2b for Adjuvant Treatment of Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Peginterferon alfa-2b (PegIntron, Sylatron) was recentl...
Abiraterone: New Drug in the Treatment of Metastatic Castration-resistant Prostate Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Abiraterone acetate (Zytiga) (an oral agent that inhibi...
What You Should Know about Denosumab (Prolia) for Increasing Bone Mass during Breast and Prostate Cancer Therapies
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indications In September 2011, the monoclonal antibody RANKL inhib...
New Indication for Cetuximab in Squamous Cell Carcinoma of the Head and Neck
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Cetuximab (Erbitux) was recently approved by the FDA for use in com...
Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers
Matthew Stenger
Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its first-in-cl...
Sunitinib and Everolimus: New Indications in Pancreatic Neuroendocrine Tumors
Matthew Stenger
With In the Clinic, The ASCO Post provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Sunitinib Indication—The oral kinase inhibitor...
Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer
Matthew Stenger
Indication Crizotinib (Xalkori) is an oral inhibitor of receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR, c-Met), and recepteur d’origine nantais (RON). In August 2011, the FDA granted the drug accelerated approval for the treatment of pa...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
Matthew Stenger
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel onc...
