In the Clinic
Nivolumab in Combination With Cisplatin Plus Gemcitabine in Treatment of Unresectable or Metastatic Urothelial Carcinoma
Matthew Stenger
Nivolumab (Opdivo) was approved for use in combination with cisplatin and gemcitabine for first-line treatment of patients with unresectable or metastatic urothelial carcinoma.1 Supporting Efficacy Data Approval was based on the open-label CheckMate 901 trial (ClinicalTrials.gov identifier NCT0303...
Belzutifan in Previously Treated Advanced Renal Cell Carcinoma
Matthew Stenger
On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial growth...
Nogapendekin Alfa Inbakicept-pmln for BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer
Matthew Stenger
On April 22, 2024, the interleukin-15 receptor agonist nogapendekin alfa inbakicept-pmln was approved for use with bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.1 Supporting Efficacy Data App...
Tarlatamab-dlle for Previously Treated Extensive-Stage SCLC
Matthew Stenger
On May 16, 2024, tarlatamab-dlle (Imdelltra) was granted accelerated approval for extensive-stage small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.1 Tarlatamab is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager. Supporting Efficacy Da...
Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
Matthew Stenger
On April 29, 2024, tisotumab vedotin-tftv (Tivdak) was granted regular approval for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.1 Tisotumab vedotin is a tissue factor–directed antibody and microtubule inhibitor conjugate. The agent was granted accelerate...
CAR T-Cell Therapy in Refractory Follicular Lymphoma
Matthew Stenger
On May 15, 2024, lisocabtagene maraleucel (Breyanzi) was granted accelerated approval for adults with relapsed or refractory follicular lymphoma with two or more prior lines of systemic therapy.1 The agent is a CD19-directed genetically modified autologous T-cell immunotherapy. Supporting Efficacy D...
Fam-Trastuzumab Deruxtecan-nxki in Unresectable or Metastatic HER2-Positive Solid Tumors
Matthew Stenger
On April 5, 2024, fam-trastuzumab deruxtecan-nxki (T-DXd) was granted accelerated approval for adults with unresectable or metastatic HER2-positive (immunohistochemistry 3+) solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.1 Supporting Effica...
Ponatinib With Chemotherapy for Newly Diagnosed Philadelphia Chromosome–Positive ALL
Matthew Stenger
On March 19, 2024, ponatinib (Iclusig) was granted accelerated approval for use with chemotherapy in adults with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL).1 Ponatinib is a multitargeted kinase inhibitor. Supporting Efficacy Data and How It Is Used Approval ...
Inotuzumab Ozogamicin for Pediatric Acute Lymphoblastic Leukemia
Matthew Stenger
On March 6, 2024, the anti-CD22 monoclonal antibody inotuzumab ozogamicin (Besponsa), which is bound to a toxic natural calicheamicin, was approved for pediatric patients aged 1 year or older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.1 Supporting Effica...
Amivantamab-vmjw in NSCLC With EGFR Exon 20 Insertion Mutations
Matthew Stenger
On March 1, 2024, amivantamab-vmjw (Rybrevant) was approved for use with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved...
Capivasertib With Fulvestrant for Previously Treated Advanced Hormone Receptor–Positive, HER2-Negative Breast Cancer
Matthew Stenger
On November 16, 2023, capivasertib (Truqap) was approved for use with fulvestrant for patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, following disease progression on at least one endocrine-based regim...
Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Matthew Stenger
On March 22, 2024, mirvetuximab soravtansine-gynx (Elahere) was granted regular approval for adult patients with folate receptor–alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens....
Tovorafenib in Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma
Matthew Stenger
On April 23, 2024, tovorafenib (Ojemda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for patients aged 6 months and older who have relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation.1 Tovorafenib is a ty...
Lu-177 Dotatate for Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors
Matthew Stenger
On April 23, 2024, lutetium Lu-177 dotatate (Lutathera) was approved for pediatric patients 12 years and older with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.1 Lu-177 dotatate is a radiolabeled somatostat...
Pembrolizumab/Chemotherapy in First-Line Treatment of HER2-Negative Advanced Gastric or GEJ Adenocarcinoma
Matthew Stenger
On November 16, 2023, pembrolizumab (Keytruda) was approved with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.1 Supporting Efficacy Data Approval ...
Eflornithine for Adult and Pediatric Patients With High-Risk Neuroblastoma
Matthew Stenger
On December 13, 2023, eflornithine (Iwilfin), an ornithine decarboxylase inhibitor, was approved for adult and pediatric patients with high-risk neuroblastoma with at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.1 This represents the first U.S....
Adjuvant Use of Alectinib in ALK-Positive NSCLC
Matthew Stenger
On April 18, 2024, the ALK inhibitor alectinib was approved by the U.S. Food and Drug Administration (FDA) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.1 Supporting Efficacy Data Approval was based ...
Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations
Matthew Stenger
On February 15, 2024, tepotinib (Tepmetko)-—a kinase inhibitor directed against MET, including variants with exon 14 skipping—was granted regular approval for patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1 ...
Pirtobrutinib in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Matthew Stenger
On December 1, 2023, pirtobrutinib (Jaypirca), a selective, noncovalent Bruton’s tyrosine kinase (BTK) inhibitor that inhibits both wild-type and C481-mutant BTK with equal low nanomolar potency and is designed to address several of the limitations of covalent BTK inhibitors, was granted accelerate...
Pembrolizumab/Chemotherapy for Advanced Biliary Tract Cancer
Matthew Stenger
On October 31, 2023, pembrolizumab (Keytruda) was approved for use with gemcitabine/cisplatin in first-line treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on the double-blind KEYNOTE-966 trial (ClinicalTria...
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 D...
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 ...
