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In the Clinic

Lung Cancer

Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations

Matthew Stenger  /  January 25, 2021

On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Supporting Eff...

Breast Cancer

Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer

Matthew Stenger  /  January 25, 2021

On December 16, 2020, margetuximab-cmkb (margetuximab) was approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.1,2 S...

Multiple Myeloma

Selinexor in Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  January 25, 2021

On December 18, 2020, selinexor was approved for use in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy.1,2 Selinexor received accelerated approval in 2019 for use in combination with dexamethasone for ...

Prostate Cancer

Relugolix for Advanced Prostate Cancer

Matthew Stenger  /  January 25, 2021

On December 18, 2020, relugolix was approved for the treatment of adult patients with advanced prostate cancer. Relugolix is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be approved in this setting.1,2 Supporting Efficacy Data Approval was based on findings in the op...

Head and Neck Cancer

Pralsetinib for RET-Altered Thyroid Cancers

Matthew Stenger  /  December 25, 2020

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, 2020, pralsetinib (Gavreto) was granted ap...

Breast Cancer

Pembrolizumab Plus Chemotherapy for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer

Matthew Stenger  /  December 25, 2020

On November 13, 2020, pembrolizumab (Keytruda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer with tumors expressing PD-L1 (Combined ...

Solid Tumors
Immunotherapy

Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow

Matthew Stenger  /  December 25, 2020

On November 25, 2020, naxita­mab-gqgk (Danyelza) was granted accelerated approval for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or...

Lymphoma
Immunotherapy

Pembrolizumab in Adult and Pediatric Classical Hodgkin Lymphoma

Matthew Stenger  /  November 25, 2020

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 14, 2020, the approval of pembrolizumab was e...

Leukemia

Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia

Matthew Stenger  /  November 25, 2020

On October 16, 2020, venetoclax was granted regular approval for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or those with comorbidities precluding intensive induction chemo...

Lung Cancer
Immunotherapy

Combination of Nivolumab and Ipilimumab for Unresectable Malignant Pleural Mesothelioma

Matthew Stenger  /  November 10, 2020

On October 2, 2020, the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) was approved for first-line treatment of adult patients with unresectable malignant pleural mesothelioma.1-3 Supporting Efficacy Data Approval was based on findings in the open-label phase III CheckMate 743 trial (C...

Multiple Myeloma
Immunotherapy

Carfilzomib and Daratumumab With Dexamethasone for Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  October 10, 2020

On August 20, 2020, carfilzomib and daratumumab were approved for use in combination with dexamethasone for treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.1-3 Supporting Efficacy Data Approval was based on findings in two clinical t...

Lung Cancer

Pralsetinib for NSCLC With RET Gene Fusions

Matthew Stenger  /  October 10, 2020

On September 4, 2020, pralsetinib (Gavreto) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for treatment of adults with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.1,2 The FDA simultaneously approved the Oncom...

Leukemia

Azacitidine Tablets for Continued Treatment in Acute Myeloid Leukemia

Matthew Stenger  /  September 25, 2020

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 1, 2020, azacitidine tabletswere approved fo...

Lymphoma
Immunotherapy

Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma

Matthew Stenger  /  September 25, 2020

On July 24, 2020, brexucabtagene autoleucel, a CD19-directed genetically modified autologous T-cell immunotherapy, was granted accelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.1,2 Brexucabtagene autoleucel is approved with a Risk Evaluation an...

Bladder Cancer
Immunotherapy

Avelumab in Maintenance Treatment of Urothelial Carcinoma

Matthew Stenger  /  September 10, 2020

On June 30, 2020, avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings in the randomized, multicenter...

Skin Cancer
Immunotherapy

Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma

Matthew Stenger  /  September 10, 2020

On July 30, 2020, atezolizumab was granted approval for use in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation–positive unresectable or metastatic melanoma.1,2 Supporting Efficacy Data Approval was based on findings from the phase III, double-blind IMspire150 tria...

Hematologic Malignancies

Oral Combination of Decitabine and Cedazuridine for Myelodysplastic Syndromes

Matthew Stenger  /  September 10, 2020

On July 7, 2020, an oral combination of the nucleoside metabolic inhibitor decitabine and the cytidine deaminase inhibitor cedazuridine was approved for treatment of adult patients with myelodysplastic syndromes (MDS), including: Previously treated and untreated, de novo, and secondary MDS with the...

Multiple Myeloma

Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  September 10, 2020

On August 5, 2020, the antibody-drug conjugate belantamab mafodotin-blmf was granted accelerated approval for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, ...

Lymphoma
Immunotherapy

Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell Lymphoma

Matthew Stenger  /  August 25, 2020

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 31, 2020, tafasitamab-cxix, a CD19-directed cytol...

Lymphoma

Tazemetostat for Adults With Relapsed or Refractory Follicular Lymphoma

Matthew Stenger  /  August 10, 2020

On June 18, 2020, the EZH2 inhibitor tazemetostat was granted accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test, and who have rec...

Breast Cancer

Fixed-Dose Subcutaneous Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in HER2-Positive Breast Cancer

Matthew Stenger  /  August 10, 2020

On June 29, 2020, a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) for subcutaneous injection was approved for the following indications1,2: Use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflam...

Lymphoma

Selinexor in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Matthew Stenger  /  August 10, 2020

On June 22, 2020, the oral nuclear export inhibitor selinexor was granted accelerated approval for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic th...

Leukemia
Immunotherapy

Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML

Matthew Stenger  /  August 10, 2020

On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial (C...

Colorectal Cancer
Immunotherapy

Pembrolizumab for First-Line Treatment of Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

Matthew Stenger  /  August 10, 2020

On June 29, 2020, pembrolizumab was approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer.1 Supporting Efficacy Data Approval was based on findings in the randomized, open-labe...

Skin Cancer

Pembrolizumab for Cutaneous Squamous Cell Carcinoma

Matthew Stenger  /  August 10, 2020

On June 24, 2020, pembrolizumab was approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.1,2 Supporting Efficacy Data Approval was based on findings in the multicenter, multicohort, open-label KEYNOTE-629 tria...

Gastroesophageal Cancer
Immunotherapy

Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma

Matthew Stenger  /  July 25, 2020

On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...

Solid Tumors
Immunotherapy

Pembrolizumab for Adult and Pediatric Patients With Tumor Mutational Burden–High Solid Tumors

Matthew Stenger  /  July 25, 2020

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 16, 2020, pembrolizumab was granted accelerated a...

Lung Cancer

Lurbinectedin in Previously Treated Metastatic Small Cell Lung Cancer

Matthew Stenger  /  July 25, 2020

On June 15, 2020, the alkylating drug lurbinectedin was granted accelerated approval for treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-based chemotherapy.1,2 Supporting Efficacy Data Accelerated approval was based on fin...

Prostate Cancer

Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  July 10, 2020

On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2 S...

Hepatobiliary Cancer
Immunotherapy

Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma

Matthew Stenger  /  July 10, 2020

On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label, p...

Multiple Myeloma

Daratumumab and Hyaluronidase-fihj for Multiple Myeloma

Matthew Stenger  /  July 10, 2020

On May 1, 2020, the combination of daratumumab and hyaluronidase-fihj was approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous (SC) dosing of daratumumab.1,2 Daratumumab and hyaluronidase-fihj is for SC use only. The prod...

Lung Cancer

Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications

Matthew Stenger  /  July 10, 2020

The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in metasta...

Lung Cancer

Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations

Matthew Stenger  /  July 10, 2020

On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of tum...

Gastrointestinal Cancer

Ripretinib in Previously Treated Advanced Gastrointestinal Stromal Tumor

Matthew Stenger  /  June 25, 2020

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 15, 2020, the receptor tyrosine kinase inhibitor r...

Prostate Cancer

Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  June 25, 2020

On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with enzalut...

Lung Cancer

Ramucirumab Plus Erlotinib in Treatment of EGFR-Mutant Metastatic NSCLC

Matthew Stenger  /  June 25, 2020

On May 29, 2020, ramucirumab was approved for use in combination with erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.1,2 Supporting Efficacy Data Approval was based on findings from the multina...

Solid Tumors

Pomalidomide for Treatment of Kaposi Sarcoma

Matthew Stenger  /  June 25, 2020

On May 14, 2020, pomalidomide was granted accelerated approval to treat adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and for Kaposi sarcoma in adult patients who are HIV-negative.1,2 Pomalidomide is available only through the restricted Pomaly...

Lung Cancer

Brigatinib for ALK-Positive Metastatic Non–Small Cell Lung Cancer

Matthew Stenger  /  June 25, 2020

On May 22, 2020, brigatinib was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diag...

Lung Cancer

Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation

Matthew Stenger  /  June 25, 2020

On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected by...

Gynecologic Cancers

Niraparib for First-Line Maintenance Treatment of Advanced Ovarian Cancer

Matthew Stenger  /  June 10, 2020

On April 29, 2020, niraparib was approved for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on ...

Breast Cancer

Sacituzumab Govitecan-hziy for Previously Treated Metastatic Triple-Negative Breast Cancer

Matthew Stenger  /  June 10, 2020

On April 22, 2020, the antibody-drug conjugate sacituzumab govitecan-hziy was granted accelerated approval for treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.1,2 Supporting Efficacy Data Approval was b...

Gynecologic Cancers

Olaparib Plus Bevacizumab in Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

Matthew Stenger  /  June 10, 2020

On May 8, 2020, olaparib was granted an expanded indication to include use in combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line plati...

Leukemia

Ibrutinib in Combination With Rituximab in Chronic Lymphocytic Leukemia

Matthew Stenger  /  June 10, 2020

On April 21, 2020, ibrutinib was granted an expanded indication for use in combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The recommended dosage of ibrutinib in CLL/SLL is 420 mg, once daily, unt...

Immunotherapy
Head and Neck Cancer
Lung Cancer

Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Matthew Stenger  /  June 10, 2020

On may 8, 2020, selpercatinib was granted accelerated approval for the following indications: Adult patients with metastatic RET fusion-positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who r...

Hepatobiliary Cancer

Pemigatinib for Previously Treated Cholangiocarcinoma With FGFR2 Rearrangement or Fusion

Matthew Stenger  /  May 25, 2020

On April 17, 2020, pemigatinib was granted accelerated approval for the treatment of adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by a U.S. Food and Drug Admi...

Solid Tumors

Selumetinib for Pediatric Neurofibromatosis Type 1 With Symptomatic, Inoperable Plexiform Neurofibromas

Matthew Stenger  /  May 25, 2020

On April 10, 2020, the oral MEK inhibitor selumetinib was approved for the treatment of patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.1,2 Selumetinib is the first therapy approved for children who have this disease. Su...

Myelodysplastic Syndromes

Luspatercept-aamt for Anemia in Adults With Myelodysplastic Syndromes

Matthew Stenger  /  May 25, 2020

On April 3, 2020, luspatercept-aamt was approved in the treatment of anemia failing to respond to an erythropoiesis-stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks.1,2 The treatment is geared toward adult patients with very low– to intermediate-risk myelodysplastic ...

Breast Cancer

Tucatinib in Previously Treated HER2-Positive Metastatic Breast Cancer

Matthew Stenger  /  May 25, 2020

On April 17, 2020, tucatinib was approved for use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. These patients included those with brain metastases and those who have received one or more prior a...

Colorectal Cancer
Immunotherapy

Encorafenib Combined With Cetuximab in Previously Treated BRAF V600E–Mutant Metastatic Colorectal Cancer

Matthew Stenger  /  May 10, 2020

On April 8, 2020, encorafenib was approved for use in combination with cetuximab for the treatment of previously treated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Encorafenib is not indicated f...

Lung Cancer
Immunotherapy

Durvalumab Plus Chemotherapy for Extensive-Stage Small Cell Lung Cancer

Matthew Stenger  /  May 10, 2020

On March 27, 2020, durvalumab (Imfinzi) was approved for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase I...

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