In the Clinic
Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression
Matthew Stenger
On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor p...
Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
Matthew Stenger
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for trea...
Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Matthew Stenger
On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have r...
Nivolumab Plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma
Matthew Stenger
On January 22, 2021, the U.S. Food and Drug Administration approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.1-3 Supporting Efficacy Data Approval was based on the findings of the phase III, open-label CheckMate 9ER trial...
Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations
Matthew Stenger
On February 3, 2021, tepotinib was granted accelerated approval for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1,2 Supporting Efficacy Data Approval was supported by findings from the...
Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive Anaplastic Large Cell Lymphoma
Matthew Stenger
On January 14, 2021, crizotinib was approved for treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.1,2 The safety and efficacy of crizotinib have not been established in older adult...
Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations
Matthew Stenger
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...
Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer
Matthew Stenger
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...
Selinexor in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
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 ...
Relugolix for Advanced Prostate Cancer
Matthew Stenger
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...
Pralsetinib for RET-Altered Thyroid Cancers
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 1, 2020, pralsetinib (Gavreto) was granted ap...
Pembrolizumab Plus Chemotherapy for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
Matthew Stenger
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 ...
Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
Matthew Stenger
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...
Pembrolizumab in Adult and Pediatric Classical Hodgkin Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 14, 2020, the approval of pembrolizumab was e...
Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia
Matthew Stenger
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...
Combination of Nivolumab and Ipilimumab for Unresectable Malignant Pleural Mesothelioma
Matthew Stenger
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...
Carfilzomib and Daratumumab With Dexamethasone for Relapsed or Refractory Multiple Myeloma
Matthew Stenger
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...
Pralsetinib for NSCLC With RET Gene Fusions
Matthew Stenger
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...
Azacitidine Tablets for Continued Treatment in Acute Myeloid Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 1, 2020, azacitidine tabletswere approved fo...
Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma
Matthew Stenger
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...
Avelumab in Maintenance Treatment of Urothelial Carcinoma
Matthew Stenger
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...
Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma
Matthew Stenger
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...
Oral Combination of Decitabine and Cedazuridine for Myelodysplastic Syndromes
Matthew Stenger
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...
Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma
Matthew Stenger
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, ...
Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 31, 2020, tafasitamab-cxix, a CD19-directed cytol...
Tazemetostat for Adults With Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
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...
Fixed-Dose Subcutaneous Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in HER2-Positive Breast Cancer
Matthew Stenger
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...
Selinexor in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Matthew Stenger
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...
Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML
Matthew Stenger
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...
Pembrolizumab for First-Line Treatment of Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
Matthew Stenger
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...
Pembrolizumab for Cutaneous Squamous Cell Carcinoma
Matthew Stenger
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...
Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma
Matthew Stenger
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,...
Pembrolizumab for Adult and Pediatric Patients With Tumor Mutational Burden–High Solid Tumors
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 16, 2020, pembrolizumab was granted accelerated a...
Lurbinectedin in Previously Treated Metastatic Small Cell Lung Cancer
Matthew Stenger
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...
Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2 S...
Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma
Matthew Stenger
On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label, p...
Daratumumab and Hyaluronidase-fihj for Multiple Myeloma
Matthew Stenger
On May 1, 2020, the combination of daratumumab and hyaluronidase-fihj was approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous (SC) dosing of daratumumab.1,2 Daratumumab and hyaluronidase-fihj is for SC use only. The prod...
Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications
Matthew Stenger
The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in metasta...
Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations
Matthew Stenger
On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of tum...
Ripretinib in Previously Treated Advanced Gastrointestinal Stromal Tumor
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 15, 2020, the receptor tyrosine kinase inhibitor r...
Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with enzalut...
Ramucirumab Plus Erlotinib in Treatment of EGFR-Mutant Metastatic NSCLC
Matthew Stenger
On May 29, 2020, ramucirumab was approved for use in combination with erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.1,2 Supporting Efficacy Data Approval was based on findings from the multina...
Pomalidomide for Treatment of Kaposi Sarcoma
Matthew Stenger
On May 14, 2020, pomalidomide was granted accelerated approval to treat adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and for Kaposi sarcoma in adult patients who are HIV-negative.1,2 Pomalidomide is available only through the restricted Pomaly...
Brigatinib for ALK-Positive Metastatic Non–Small Cell Lung Cancer
Matthew Stenger
On May 22, 2020, brigatinib was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diag...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
Matthew Stenger
On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected by...
Niraparib for First-Line Maintenance Treatment of Advanced Ovarian Cancer
Matthew Stenger
On April 29, 2020, niraparib was approved for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on ...
Sacituzumab Govitecan-hziy for Previously Treated Metastatic Triple-Negative Breast Cancer
Matthew Stenger
On April 22, 2020, the antibody-drug conjugate sacituzumab govitecan-hziy was granted accelerated approval for treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.1,2 Supporting Efficacy Data Approval was b...
Olaparib Plus Bevacizumab in Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Matthew Stenger
On May 8, 2020, olaparib was granted an expanded indication to include use in combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line plati...
Ibrutinib in Combination With Rituximab in Chronic Lymphocytic Leukemia
Matthew Stenger
On April 21, 2020, ibrutinib was granted an expanded indication for use in combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The recommended dosage of ibrutinib in CLL/SLL is 420 mg, once daily, unt...
Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
Matthew Stenger
On may 8, 2020, selpercatinib was granted accelerated approval for the following indications: Adult patients with metastatic RET fusion-positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who r...
