In the Clinic
Zanubrutinib in Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
On March 7, 2024, the Bruton’s tyrosine kinase inhibitor zanubrutinib (Brukinsa) was granted accelerated approval in combination with the monoclonal antibody obinutuzumab for patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1 Supporting Efficacy Da...
Lifileucel for Unresectable or Metastatic Melanoma
Matthew Stenger
On February 16, 2024, lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, was granted accelerated approval for adults with unresectable or metastatic melanoma previously treated with a PD-1–blocking antibody, and if BRAF V600 mutation–positive, a BRAF inhibitor with or without a M...
Adjuvant Nivolumab in Stage IIB/C Melanoma
Matthew Stenger
On October 13, 2023, nivolumab was approved for adjuvant treatment of completely resected stage IIB/C melanoma in patients aged 12 years and older.1 Supporting Efficacy Data Approval was based on findings in the double-blind CheckMate 76K trial (ClinicalTrials.gov identifier NCT04099251), in which...
Enfortumab Vedotin-ejfv Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer
Matthew Stenger
On December 15, 2023, enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) was approved for patients with locally advanced or metastatic urothelial cancer.1,2 Supporting Efficacy Data Approval was based on findings in the open-label EV-302 trial (ClinicalTrials.gov identif...
Erdafitinib for Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
Matthew Stenger
On January 19, 2024, erdafitinib (Balversa) was approved for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by a U.S. Food & Drug Administration–approved companion diagnostic test, whose disease has progressed on or aft...
Liposomal Irinotecan in First-Line Treatment of Metastatic Pancreatic Adenocarcinoma
Matthew Stenger
On February 13, 2024, the U.S. Food and Drug Administration approved liposomal irinotecan (Onivyde) for use with oxaliplatin, fluorouracil, and leucovorin in the first-line treatment of metastatic pancreatic adenocarcinoma.1 Supporting Efficacy Data Approval was based on the open-label NAPOLI 3 tr...
Repotrectinib for ROS1 Fusion–Positive Advanced NSCLC
Matthew Stenger
On November 15, 2023, repotrectinib (Augtyro) was approved for locally advanced or metastatic ROS1 fusion–positive non–small cell lung cancer (NSCLC).1 This is the first U.S. Food and Drug Administration approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyr...
Osimertinib With Chemotherapy for EGFR-Mutated NSCLC
Matthew Stenger
On February 16, 2024, osimertinib (Tagrisso) was approved by the U.S. Food and Drug Administraton (FDA) with pemetrexed and platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with tumors having EGFR exon 19 deletions or exon 21 L858R mutat...
Fruquintinib in Refractory Metastatic Colorectal Cancer
Matthew Stenger
On November 8, 2023, fruquintinib (Fruzaqla) was approved for adults with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; and—if RAS wild-type and medically appropriate—an anti-EGFR therapy.1 Supporting Effica...
Use of Enzalutamide in Nonmetastatic Castration-Sensitive Prostate Cancer With Biochemical Recurrence
Matthew Stenger
On November 16, 2023, the androgen receptor inhibitor enzalutamide was approved for use in patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.1 Supporting Efficacy Data Approval was based on the EMBARK trial (ClinicalTrials.gov ...
Neoadjuvant/Adjuvant Pembrolizumab in Resectable NSCLC
Matthew Stenger
On October 16, 2023, pembrolizumab was approved for use with platinum-containing chemotherapy as neoadjuvant treatment and as single-agent adjuvant treatment in patients with resectable (tumors ≥ 4 cm or node-positive) non–small cell lung cancer (NSCLC).1 Supporting Efficacy Data Approval was base...
Encorafenib Plus Binimetinib in Metastatic NSCLC With BRAF V600E Mutation
Matthew Stenger
On October 11, 2023, the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) was approved for patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA als...
Bosutinib in Pediatric Chronic Myeloid Leukemia
Matthew Stenger
On September 26, 2023, bosutinib (Bosulif) was approved for pediatric patients aged 1 year and older with chronic-phase Philadelphia chromosome–positive chronic myeloid leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy.1 New capsule dosage form strengths of 50 mg and...
Melphalan-Based Liver-Directed Therapy for Metastatic Uveal Melanoma
Matthew Stenger
On August 14, 2023, the Hepzato Kit—melphalan for injection/hepatic delivery system—was approved as a liver-directed treatment for adults with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver.1 Patients must have either no extrahepatic disease or extrahepatic ...
Accelerated Approval Granted for Use of Elranatamab-bcmm in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On August 14, 2023, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager elranatamab-bcmm was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of ther...
Accelerated Approval Granted for Talquetamab-tgvs in Treatment of Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On August 9, 2023, the bispecific GPRC5D (G protein–coupled receptor, class C, group 5)-directed CD3 T-cell engager talquetamab-tgvs was granted accelerated approval by the U.S. Food and Drug Administration for treatment of adults with relapsed or refractory multiple myeloma who have received at lea...
Fixed-Dose Niraparib and Abiraterone Plus Prednisone in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On August 11, 2023, the fixed-dose combination of the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate plus prednisone was approved for patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer, as determined by a U.S. Food and Drug Admi...
Quizartinib in Newly Diagnosed FLT3-ITD–Positive Acute Myeloid Leukemia
Matthew Stenger
On July 20, 2023, quizartinib was approved for use with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy in adults with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication (ITD...
Trifluridine/Tipiracil Plus Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Matthew Stenger
On August 2, 2023, the fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, was approved for use with bevacizumab for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemoth...
Dostarlimab-gxly With Chemotherapy for Endometrial Cancer
Matthew Stenger
On July 31, 2023, the immune checkpoint inhibitor dostarlimab-gxly was approved by the U.S. Food and Drug Administration (FDA) for use with carboplatin and paclitaxel, followed by single-agent dostarlimab, for patients with primary advanced or recurrent endometrial cancer that is mismatch repair–def...
Talazoparib With Enzalutamide in HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On June 20, 2023, the PARP inhibitor talazoparib was approved for use with enzalutamide in homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.1 Supporting Efficacy Data Approval was based on findings in the multicohort, double-blind TALAPRO-2 trial (...
Glofitamab-gxbm for Select Relapsed or Refractory Large B-Cell Lymphomas
Matthew Stenger
On June 15, 2023, the bispecific CD20-directed CD3 T-cell engager glofitamab-gxbm was granted accelerated approval for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma after at least two lines of sys...
Olaparib With Abiraterone and Prednisone or Prednisolone for BRCA-Mutated, Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On May 31, 2023, the PARP inhibitor olaparib was approved by the U.S. Food and Drug Administration (FDA) with abiraterone and prednisone or prednisolone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.1 Ap...
Epcoritamab-bysp in Treatment of Relapsed or Refractory B-Cell Lymphomas
Matthew Stenger
On May 19, 2023, epcoritamab-bysp was granted accelerated approval by the U.S. Food and Drug Administration for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two ...
Polatuzumab Vedotin-piiq for Previously Untreated DLBCL–Not Otherwise Specified and High-Grade B-Cell Lymphoma
Matthew Stenger
On April 19, 2023, polatuzumab vedotin-piiq was approved for use with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for patients with diffuse large B-cell lymphoma (DLBCL)–not otherwise specified or those with high-grade B-cell lymphoma who have an International Prognost...
Retifanlimab-dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
Matthew Stenger
On March 22, 2023, the anti–PD-1 antibody retifanlimab-dlwr was granted accelerated approval for adults with metastatic or recurrent locally advanced Merkel cell carcinoma.1 Supporting Efficacy Data Approval was based on findings in POD1UM-201 (ClinicalTrials.gov identifier NCT03599713), a multice...
Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Incidence of Infection in Hematologic Malignancies
Matthew Stenger
On April 17, 2023, omidubicel-onlv was approved for use in adult and pediatric patients (≥ 12 years) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.1 ...
Enfortumab Vedotin-ejfv With Pembrolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
Matthew Stenger
On April 3, 2023, enfortumab vedotin-ejfv with pembrolizumab was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy.1,2 Enfortumab vedotin-ejfv is an antibody-drug conjugate targeting nectin 4. Suppo...
Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Matthew Stenger
On January 27, 2023, pirtobrutinib was granted accelerated approval for treatment of relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.1 Pirtobrutinib is a noncovalent inhibitor of BTK. Supporting Efficacy ...
Dabrafenib With Trametinib for Pediatric Low-Grade Glioma With BRAF V600E Mutation
Matthew Stenger
On March 16, 2023, dabrafenib with trametinib was approved for pediatric patients aged 1 year and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.1,2 The U.S. Food and Drug Administration also approved new oral formulations of both drugs suitable for patients who ...
Abemaciclib Expanded Indication for Adjuvant Use in HR-Positive, HER2-Negative, Node-Positive Early Breast Cancer
Matthew Stenger
On March 3, 2023, abemaciclib was approved for use with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.1 Abemaciclib was previously approved in...
Regular Approval for Dostarlimab-gxly in dMMR Recurrent or Advanced Endometrial Cancer
Matthew Stenger
On February 9, 2023, dostarlimab-gxly was granted regular approval for adults with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a U.S. Food and Drug Administration–approved test, whose disease has progressed on or following a prior platinum-containing r...
Tucatinib With Trastuzumab in Previously Treated RAS Wild-Type HER2-Positive Advanced Colorectal Cancer
Matthew Stenger
On January 19, 2023, tucatinib was grated accelerated approval for use in combination with trastuzumab for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.1 Supporting Efficacy Dat...
Sacituzumab Govitecan-hziy in HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Matthew Stenger
On February 3, 2023, sacituzumab govitecan-hziy was approved for unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/in situ hybridization–negative) breast cancer who have received endocrine-based therapy and at l...
Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
Matthew Stenger
On January 27, 2023, elacestrant was approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine ...
Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Matthew Stenger
On January 19, 2023, the kinase inhibitor zanubrutinib was approved for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1 Supporting Efficacy Data Approval was based on findings in the SEQUOIA trial (ClinicalTrials.gov identifier NCT03336333) in patients with tr...
Mosunetuzumab-axgb for Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
On December 22, 2022, mosunetuzumab-axgb, a bispecific CD20-directed CD3 T-cell engager, was granted accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1 Supporting Efficacy Data Approval was based on findings in the multicen...
First Adenoviral Vector–Based Gene Therapy for High-Risk BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer
Matthew Stenger
On December 16, 2022, nadofaragene firadenovec-vncg, an adenoviral vector–based gene therapy, was approved for patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.1 Supporting Efficacy Data A...
Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation
Matthew Stenger
On December 1, 2022, the IDH1 inhibitor olutasidenib was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Abbott RealT...
Tremelimumab-actl in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
Matthew Stenger
On October 21, 2022, tremelimu-mab-actl was approved by the U.S. Food and Drug Administration (FDA) for use in combination with durvalumab in the treatment of unresectable hepatocellular carcinoma.1 Supporting Efficacy Data Approval was based on a comparison of overall survival in the tremelimumab...
Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Matthew Stenger
On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted mirvetuximab soravtansine-gynx accelerated approval for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three pri...
Sodium Thiosulfate to Reduce the Risk of Cisplatin-Related Ototoxicity in Pediatric Patients With Localized Solid Tumors
Matthew Stenger
On September 20, 2022, sodium thiosulfate was approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients (aged ≥ 1 month) with localized, nonmetastatic solid tumors.1 Supporting Efficacy Data Approval was based on findings in the multicenter open-label SIOPEL 6 (Cli...
Ivosidenib/Azacitidine for Newly Diagnosed IDH1-Mutant Acute Myeloid Leukemia in Patients Aged 75 or Older or With Comorbidities
Matthew Stenger
On May 25, 2022, ivosidenib was approved for use in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration–approved test, in patients aged 75 or older or in those who have comorbidities precluding t...
Tremelimumab Combined With Durvalumab and Platinum-Based Chemotherapy in Metastatic NSCLC
Matthew Stenger
On November 10, 2022, tremelimu-mab in combination with durvalumab and platinum-based chemotherapy was approved for patients with metastatic non–small cell lung cancer (NSCLC) with no sensitizing EGFR mutation or ALK genomic tumor aberrations.1 Supporting Efficacy Data Approval was supported by fi...
Brentuximab Vedotin Combined With Chemotherapy in Pediatric Classical Hodgkin Lymphoma
Matthew Stenger
On November 10, 2022, brentuximab vedotin was approved for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged ≥ 2 years with previously untreated high-risk classical Hodgkin lymphoma.1 Supporting Efficacy Data Approval was supp...
Cemiplimab/Chemotherapy Combination in Advanced NSCLC With No EGFR, ALK, or ROS1 Aberrations
Matthew Stenger
On November 8, 2022, cemiplimab-rwlc was approved for use in combination with platinum-based chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.1 Supporting Efficacy Data Approval was supported by findings in th...
Teclistamab in the Treatment of Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On October 25, 2022, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager teclistamab-cqyv was granted accelerated approval for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome i...
Dabrafenib in Combination With Trametinib for Unresectable or Metastatic Solid Tumors With BRAF V600E Mutation
Matthew Stenger
On June 22, 2022, dabrafenib in combination with trametinib was granted accelerated approval for treatment of adult and pediatric patients (aged 6 and older) with unresectable or metastatic solid tumors with BRAF V600E mutation whose disease progressed following prior treatment and who have no satis...
Durvalumab Plus Chemotherapy in Advanced Biliary Tract Cancer
Matthew Stenger
On September 2, 2022, durvalumab was approved for use in combination with gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind TOPAZ-1 trial (NCT03875235), in which...
Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements
Matthew Stenger
On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy Data...
