Advertisement In the Clinic

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

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

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

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

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

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

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

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

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

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...

Matthew Stenger / December 10, 2019

Niraparib for Homologous Recombination Deficiency–Positive Advanced Ovarian Cancer

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...

The ASCO Post Staff / December 10, 2019

First-Line Pembrolizumab Plus Axitinib for Advanced Renal Cell Carcinoma

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...

Matthew Stenger / December 10, 2019

Zanubrutinib in Previously Treated Mantle Cell Lymphoma

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

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

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

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

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

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 ...

Matthew Stenger / November 10, 2019

Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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...

The ASCO Post Staff / November 10, 2019

Daratumumab Combination Therapy for Patients With Multiple Myeloma Who Are Eligible for Transplantation

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...

Matthew Stenger / October 25, 2019

Pembrolizumab/Lenvatinib in Advanced Endometrial Carcinoma Without Microsatellite Instability–High or Mismatch Repair–Deficient Disease

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...

Matthew Stenger / October 25, 2019

Fedratinib for Myelofibrosis

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...

Matthew Stenger / October 10, 2019

Entrectinib for NTRK-Positive Solid Tumors and ROS1-Positive Lung Cancer

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...

Matthew Stenger / October 10, 2019

Biosimilar to Trastuzumab in HER2-Overexpressing Breast, Metastatic Breast, and Metastatic Gastric Cancers

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...

Matthew Stenger / October 10, 2019

Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer

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...

Matthew Stenger / September 25, 2019

Adjuvant Treatment With Ado-trastuzumab Emtansine in HER2-Positive Early Breast Cancer

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 ...

Matthew Stenger / September 25, 2019

Ramucirumab in Hepatocellular Carcinoma

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...

Matthew Stenger / September 25, 2019

Avelumab Plus Axitinib in Advanced Renal Cell Carcinoma

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ...

Matthew Stenger / July 25, 2019

Brentuximab Vedotin in Untreated Systemic Anaplastic Large-Cell Lymphoma and CD30-Expressing Peripheral T-Cell Lymphomas

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...

Matthew Stenger / June 10, 2019

Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL

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 ...

Matthew Stenger / May 25, 2019

Erdafitinib for Metastatic Urothelial Carcinoma

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...

Matthew Stenger / March 25, 2019

Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer

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 ...

Matthew Stenger / March 10, 2019

Cabozantinib for Hepatocellular Carcinoma Previously Treated With Sorafenib

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...

Matthew Stenger / February 25, 2019

Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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...

Matthew Stenger / November 10, 2018

Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy

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...

Matthew Stenger / November 10, 2018

Nilotinib for Pediatric Patients With Philadelphia Chromosome–Positive CML in Chronic Phase

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...

Matthew Stenger / October 25, 2018

Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma

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...

Genomics/Genetics

Everolimus Tablets for Oral Suspension for Tuberous Sclerosis Complex–Associated Partial-Onset Seizures

Matthew Stenger / October 25, 2018

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 ...

Matthew Stenger / October 10, 2018

Osimertinib in First-Line Treatment of EGFR-Mutant Metastatic NSCLC

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...

Matthew Stenger / October 10, 2018

Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome

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...

Matthew Stenger / October 10, 2018

Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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...

Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma

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

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

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

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...

Matthew Stenger / September 10, 2018

Ipilimumab in Combination With Nivolumab for MSI-H or dMMR Metastatic Colorectal Cancer

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...

Matthew Stenger / September 10, 2018

Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

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)...

Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer

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

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

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

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 ...

Matthew Stenger / August 10, 2018

Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations

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...

Matthew Stenger / August 10, 2018

Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

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...

Matthew Stenger / August 10, 2018

Durvalumab After Chemoradiation in Unresectable Stage III NSCLC

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

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

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

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

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....

Matthew Stenger and compiled by Sarah Jackson / July 25, 2018

Circulating Tumor Cells and Adjuvant Radiotherapy in Early Breast Cancer

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...

Matthew Stenger / July 10, 2018

Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer

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...

Matthew Stenger / June 10, 2018

Dabrafenib Plus Trametinib for Thyroid Cancer, Melanoma With BRAF Mutations

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 ...

Matthew Stenger / May 25, 2018

Tisagenlecleucel for Adults With Relapsed or Refractory Large B-Cell Lymphoma

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...

Matthew Stenger / May 25, 2018

Brentuximab Vedotin in Previously Untreated Stage III or IV Classical Hodgkin Lymphoma

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...

Matthew Stenger / May 10, 2018

Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR Mutations

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...

Matthew Stenger / May 10, 2018

Nilotinib Label Updated to Provide Treatment Discontinuation Recommendations for CML With Sustained Molecular Response

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...

Matthew Stenger / May 10, 2018

Nivolumab in Adjuvant Treatment of Melanoma

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...

Matthew Stenger / March 25, 2018

Venetoclax in Chronic Lymphocytic Leukemia Progressing After Ibrutinib

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 ...

Matthew Stenger / March 25, 2018

Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer

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

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

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...

CNS Cancers

Bevacizumab in Recurrent Glioblastoma

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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...

Matthew Stenger / September 25, 2017

Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL

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...

Matthew Stenger / September 25, 2017

Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia

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...

Matthew Stenger / September 25, 2017

Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib

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...

Matthew Stenger / September 10, 2017

Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin

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...

Matthew Stenger / September 10, 2017

Pembrolizumab in Classical Hodgkin Lymphoma

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...

Matthew Stenger / September 10, 2017

Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis

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...

Matthew Stenger / June 10, 2017

Combination Therapy With Pembrolizumab in Metastatic Nonsquamous NSCLC

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 ...

Matthew Stenger / May 25, 2017

Niraparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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...

Matthew Stenger / May 25, 2017

Palbociclib Combined With Aromatase Inhibitor in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

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...

Matthew Stenger / May 25, 2017

Osimertinib in Metastatic EGFR T790M–Mutant NSCLC After EGFR Inhibitor Therapy

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 ...

Matthew Stenger / May 10, 2017

Avelumab in Merkel Cell Carcinoma

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 ...

Matthew Stenger / May 10, 2017

Lenalidomide as Maintenance Therapy in Multiple Myeloma After Autologous Stem Cell Transplantation

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...

Matthew Stenger / April 25, 2017

Nivolumab in Urothelial Carcinoma After Platinum Therapy

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 ...

Matthew Stenger / April 10, 2017

Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

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...

Matthew Stenger / March 10, 2017

Ibrutinib in Marginal Zone Lymphoma

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...

Matthew Stenger / January 25, 2017

Rucaparib in Previously Treated BRCA Mutation–Associated Ovarian Cancer

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)...

Matthew Stenger / December 10, 2016

Daratumumab in Previously Treated Multiple Myeloma

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...

Matthew Stenger / December 10, 2016

Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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...

Matthew Stenger / November 25, 2016

Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer

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...

Matthew Stenger / November 10, 2016

Atezolizumab in Previously Treated Metastatic NSCLC

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...

Matthew Stenger / November 10, 2016

Modified Indication for Erlotinib in Advanced Non–Small Cell Lung Cancer

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 ...

Matthew Stenger / November 10, 2016

Olaratumab in Soft-Tissue Sarcoma

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...

Matthew Stenger / October 25, 2016

Modification of Dosage Regimen for Nivolumab in Renal Cell Carcinoma, Melanoma, and NSCLC

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...

Matthew Stenger / September 10, 2016

Use of Pembrolizumab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Therapy

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...

Matthew Stenger / June 10, 2016

Nivolumab in Classical Hodgkin Lymphoma

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...

Matthew Stenger / June 10, 2016

PD-L1 Inhibitor Atezolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

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...

Matthew Stenger / June 10, 2016

Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma

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...

Matthew Stenger / May 25, 2016

Venetoclax for Previously Treated Chronic Lymphocytic Leukemia With 17p Deletion

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...

Matthew Stenger / May 25, 2016

Cabozantinib in Advanced Renal Cell Carcinoma

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...

Matthew Stenger / May 10, 2016

Relatives of Patients With Carcinoma of Unknown Primary at Increased Risk for This and Other Cancers

Charlotte Bath / May 25, 2016

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...

Symptom Management

Defibrotide Sodium for Hepatic Veno-occlusive Disease After HSCT

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 ...

Matthew Stenger / April 10, 2016

Crizotinib in ROS1-Positive Metastatic Non–Small Cell Lung Cancer

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...

Matthew Stenger / March 25, 2016

Everolimus in Advanced Neuroendocrine Tumors

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...

Matthew Stenger / March 25, 2016

Palbociclib Combined With Fulvestrant in Advanced Breast Cancer Progressing After Endocrine Therapy

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...

Matthew Stenger / March 25, 2016

Obinutuzumab in Relapsed or Refractory Follicular Lymphoma

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...

Matthew Stenger / March 10, 2016

Carfilzomib Plus Dexamethasone in Previously Treated Multiple Myeloma

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...

Matthew Stenger / March 10, 2016

Eribulin Mesylate in Advanced Liposarcoma Previously Treated With an Anthracycline

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...

Matthew Stenger / February 25, 2016

Ofatumumab for Extended Treatment of Patients With Recurrent or Progressive Chronic Lymphocytic Leukemia

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...

Matthew Stenger / February 25, 2016

Nivolumab Plus Ipilimumab in Unresectable or Metastatic Melanoma Regardless of BRAF Mutation Status

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 ...

Matthew Stenger / February 10, 2016

Expanded Approval of Pembrolizumab in Unresectable or Metastatic Melanoma

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...

Matthew Stenger / February 10, 2016

Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib

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...

Matthew Stenger / January 25, 2016

Elotuzumab in Previously Treated Multiple Myeloma

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...

Matthew Stenger / January 25, 2016

Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity

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...

Matthew Stenger / December 25, 2015

Nivolumab in Advanced Renal Cell Carcinoma After Antiangiogenic Therapy

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...

Matthew Stenger / December 25, 2015

Nivolumab as Single-Agent Treatment for BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

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...

Matthew Stenger / December 25, 2015

Necitumumab in Metastatic Squamous Non–Small Cell Lung Cancer

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

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

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

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

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

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

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

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 ...

Pancreatic Cancer

Irinotecan Liposome Injection Plus Fluorouracil/Leucovorin to Treat Patients With Metastatic Pancreatic Cancer

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...

Matthew Stenger / November 10, 2015

Nivolumab in Metastatic NSCLC After Platinum Therapy

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-...

Matthew Stenger / October 25, 2015

Nivolumab in Combination With Ipilimumab in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

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...

Matthew Stenger / October 25, 2015

Pembrolizumab in Previously Treated PD-L1–Positive Metastatic NSCLC

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...

Symptom Management

Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting

Matthew Stenger / September 25, 2015

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...

Matthew Stenger / September 10, 2015

Brentuximab Vedotin for Consolidation Therapy in High-Risk Hodgkin Lymphoma

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 ...

Matthew Stenger / August 25, 2015

Gefitinib in EGFR-Mutant Metastatic NSCLC

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 ...

Matthew Stenger / August 25, 2015

Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

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...

Matthew Stenger / August 25, 2015

Sonidegib in Basal Cell Carcinoma

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...

Matthew Stenger / May 25, 2015

Ramucirumab With FOLFIRI in Metastatic Colorectal Cancer

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...

CNS Cancers

Dinutuximab in Pediatric High-Risk Neuroblastoma

Matthew Stenger / April 10, 2015

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 ...

Issues in Oncology

Matthew Stenger / April 10, 2015

Biosimilar Filgrastim-sndz in Filgrastim Indications

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...

Matthew Stenger / April 10, 2015

Nivolumab in Metastatic Squamous Non–Small Cell Lung Cancer After Platinum Therapy

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...

Matthew Stenger / March 25, 2015

Lenalidomide in Combination With Dexamethasone in Newly Diagnosed Multiple Myeloma

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)...

Matthew Stenger / March 25, 2015

Panobinostat in Combination With Bortezomib‑Dexamethasone in Previously Treated Multiple Myeloma

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...

Matthew Stenger / March 10, 2015

Lenvatinib in Advanced Radioiodine-Refractory Differentiated Thyroid Cancer

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 ...

Matthew Stenger / March 10, 2015

Palbociclib as Initial Endocrine-Based Therapy in Postmenopausal Women With Metastatic Breast Cancer

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...

The ASCO Post / February 25, 2015

Ibrutinib for Waldenström’s Macroglobulinemia

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)...

The ASCO Post / February 25, 2015

Blinatumomab in Philadelphia Chromosome–Negative Relapsed/Refractory B-Cell Precursor ALL

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...

Matthew Stenger / February 10, 2015

Ruxolitinib for Polycythemia Vera

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...

Matthew Stenger / February 10, 2015

Ramucirumab in Metastatic Non–Small Cell Lung Cancer

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

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...

Neuroendocrine Tumors

Lanreotide in Gastroenteropancreatic Neuroendocrine 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. On December 16, 2014, lanreotide (Somatuline depot injection) wa...

Gardasil 9 Adds Protection Against Cancer Caused by Additional Human Papillomavirus Types

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

The ASCO Post / December 1, 2014

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

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...

Matthew Stenger / November 15, 2014

Bortezomib in Previously Untreated Mantle Cell Lymphoma

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...

Matthew Stenger / November 15, 2014

Fixed-Combination Netupitant/Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting

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...

Matthew Stenger / November 15, 2014

Ramucirumab in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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 ...

Matthew Stenger / October 15, 2014

First Approval of PD-1 Inhibitor: Pembrolizumab in Unresectable or Metastatic Melanoma

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...

Matthew Stenger / October 15, 2014

Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

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...

Matthew Stenger / September 1, 2014

Bortezomib Retreatment in Multiple Myeloma

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...

Matthew Stenger / September 1, 2014

Bevacizumab in Persistent, Recurrent, or Metastatic Cervical Cancer

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...

Matthew Stenger / August 15, 2014

Idelalisib for Relapsed CLL in Combination With Rituximab and for Relapsed Follicular Lymphoma or Small Lymphocytic Lymphoma

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 ...

Matthew Stenger / August 15, 2014

Ibrutinib in Previously Treated CLL and CLL With 17p Deletion

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...

Matthew Stenger / July 25, 2014

Belinostat for Relapsed/Refractory Peripheral T-Cell Lymphoma

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 ...

Matthew Stenger / July 10, 2014

Panitumumab Plus FOLFOX for KRAS Wild-Type Metastatic Colorectal Cancer

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...

Matthew Stenger / July 10, 2014

Siltuximab for Multicentric Castleman’s Disease

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 ...

Matthew Stenger / June 10, 2014

Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia

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...

Matthew Stenger / June 10, 2014

Ceritinib in ALK-Positive Metastatic NSCLC Patients With Progression on or Intolerance to Crizotinib

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...

Matthew Stenger / May 15, 2014

Ofatumumab Plus Chlorambucil for Previously Untreated CLL in Patients Not Treatable With Fludarabine-Based Regimens

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...

Matthew Stenger / May 15, 2014

Ramucirumab for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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...

Matthew Stenger / March 15, 2014

Ibrutinib for Previously Treated Chronic Lymphocytic Leukemia

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...

Matthew Stenger / February 15, 2014

Trametinib and Dabrafenib in Combination for Unresectable or Metastatic Melanoma With BRAF V600E or V600K Mutations

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 / February 15, 2014

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 / February 15, 2014

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...

Jo Cavallo / February 15, 2014

Ongoing NCI-Funded Clinical Trials Actively Recruiting Patients With Hematologic Cancers: Multiple Myeloma

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...

Matthew Stenger / January 15, 2014

Sorafenib in Differentiated Thyroid Carcinoma

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...

Matthew Stenger / December 15, 2013

Ibrutinib in Previously Treated Mantle Cell Lymphoma

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...

Matthew Stenger / December 1, 2013

Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia

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...

Matthew Stenger / November 15, 2013

Pertuzumab in Neoadjuvant Treatment of HER2-Positive Early Breast Cancer

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...

Pancreatic Cancer

Nab-Paclitaxel in Metastatic Pancreas Cancer

Matthew Stenger / November 1, 2013

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...

Matthew Stenger / August 15, 2013

Afatinib as First-line Treatment for Metastatic NSCLC with EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations

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 ...

Matthew Stenger / July 25, 2013

Lenalidomide in Relapsed/Progressed Mantle Cell Lymphoma after Two Prior Therapies Including Bortezomib

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...

Matthew Stenger / July 25, 2013

Denosumab in Adults and Skeletally Mature Adolescents with Giant Cell Tumor of Bone

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...

Matthew Stenger / July 10, 2013

Radium-223 Dichloride for Castration-resistant Prostate Cancer with Symptomatic Bone Metastases

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 ...

Matthew Stenger / July 10, 2013

Erlotinib in First-line Treatment of Metastatic NSCLC with EGFR Exon 19 Deletion or Exon 21 (L858R) Substitution

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...

Matthew Stenger / June 25, 2013

Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E 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, dabrafenib (Tafinlar) was approved fo...

Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation

The ASCO Post / June 25, 2013

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 ...

Matthew Stenger / April 15, 2013

Ado-Trastuzumab Emtansine in Metastatic Breast Cancer

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...

Matthew Stenger / March 15, 2013

Issues in Oncology

Pomalidomide in Previously Treated Multiple Myeloma

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...

Matthew Stenger / March 1, 2013

Bevacizumab plus Chemotherapy after Progression of Metastatic Colorectal Cancer on First-line Therapy Including Bevacizumab

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...

Matthew Stenger / February 15, 2013

Abiraterone in Patients with Metastatic Castration-resistant Prostate Cancer and No Prior Chemotherapy

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...

Matthew Stenger / February 15, 2013

Ponatinib in Chronic Myeloid Leukemia and Philadelphia Chromosome–positive Acute Lymphoblastic Leukemia

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...

Matthew Stenger / February 1, 2013

Cabozantinib in Metastatic Medullary Thyroid Cancer

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...

Matthew Stenger / January 15, 2013

Omacetaxine for Chronic or Accelerated Phase CML Patients with Resistance/Intolerance to Tyrosine Kinase Inhibitors

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...

Matthew Stenger / December 15, 2012

Liposomal Vincristine for Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

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 ...

Matthew Stenger / December 15, 2012

SIDEBAR: REPORT ADVERSE EVENTS

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...

CNS Cancers

Revised Everolimus Dosing and New Safety/Efficacy Data for Approval in Subependymal Giant Cell Astrocytoma

Matthew Stenger / December 15, 2012

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 / November 15, 2012

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 / November 15, 2012

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 / November 15, 2012

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...

Matthew Stenger / November 1, 2012

Vismodegib: Novel Agent for Treating Advanced Basal Cell Carcinoma

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...

Matthew Stenger / October 15, 2012

Bosutinib in Chronic Myelogenous Leukemia Patients with Resistance or Intolerance of Prior Therapy

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 ...

Matthew Stenger / October 15, 2012

Enzalutamide for Metastatic Castrate-resistant Prostate Cancer

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...

Matthew Stenger / September 15, 2012

New Indication for Cetuximab plus FOLFIRI to Treat EGFR-positive, Wild-type KRAS Metastatic Colorectal Cancer

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 / September 15, 2012

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 ...

Matthew Stenger / September 1, 2012

Carfilzomib: New Drug with Accelerated Approval for Multiple Myeloma

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...

Matthew Stenger / August 15, 2012

Pertuzumab: New Drug for HER2-positive Metastatic Breast Cancer

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...

Matthew Stenger / July 15, 2012

Pazopanib: New Drug for Advanced Soft-tissue Sarcoma

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 / July 1, 2012

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...

Matthew Stenger / June 15, 2012

Newest Indication for Rituximab as Maintenance Treatment in Non‑Hodgkin Lymphoma

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 / June 15, 2012

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 ...

Matthew Stenger / May 15, 2012

Vandetanib: New Drug for Unresectable Medullary Thyroid Cancer

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

Matthew Stenger / May 1, 2012

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...

Matthew Stenger / April 15, 2012

Erwinia chrysanthemi Asparaginase for Acute Lymphoblastic Leukemia in Patients with Hypersensitivity to E coli–derived Asparaginase

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...

Matthew Stenger / March 15, 2012

What You Need to Know About Axitinib, New Agent for Treating Advanced Renal Cell Carcinoma

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...

Matthew Stenger / March 1, 2012

What You Should Know about Peginterferon Alfa-2b for Adjuvant Treatment of Melanoma

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...

Matthew Stenger / February 15, 2012

Abiraterone: New Drug in the Treatment of Metastatic Castration-resistant Prostate Cancer

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...

Matthew Stenger / January 15, 2012

What You Should Know about Denosumab (Prolia) for Increasing Bone Mass during Breast and Prostate Cancer Therapies

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...

Matthew Stenger / January 1, 2012

New Indication for Cetuximab in Squamous Cell Carcinoma of the Head and Neck

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...

Matthew Stenger / December 15, 2011

Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers

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...

Matthew Stenger / November 15, 2011

Sunitinib and Everolimus: New Indications in Pancreatic Neuroendocrine Tumors

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...

Matthew Stenger / November 1, 2011

Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer

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...