The FDA has granted approval to olaparib (Lynparza®, AstraZeneca Pharmaceuticals) with abiraterone and either prednisone or prednisolone for treatment of deleterious or suspected deleterious breast cancer gene–mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as detected by an FDA-approved companion diagnostic test.   Why it matters: "Current treatment options in the first-line setting of mCRPC mainly comprise next-generation hormonal agents (eg, abiraterone and enzal...

The FDA has approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified. This approval includes high-grade B-cell lymphoma after two or more lines of systemic therapy and DLBCL arising from indolent lymphoma.   Why it matters: "Treatment regimens incorporating anti-CD20 monoclonal antibodies have become the standard of care for DLBCL and follicular lymphoma; however, intrinsic or acquired resistance will occ...

The FDA has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for treatment of mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen or who are not eligible for curative surgery or radiation. Diagnosis is determined by an FDA-approved test. "Endometrial cancer is the most common gynecologic malignancy in the developed world and has the highest rate of dMMR/microsatellite instability–high (MSI-H) s...

The FDA has approved polatuzumab vedotin-piiq (Polivy®, Genentech, Inc.) plus R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) for adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL); including those who have an International Prognostic Index (IPI) score of 2 or greater. Why it matters: "Although most patients (depending on prognostic factors) can be cured with R-CHOP (rituximab, cyclo...

The FDA has granted accelerated approval to retifanlimab-dlwr (Zynyz™, Incyte), a programmed cell death protein 1 (PD-1)–blocking antibody, for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). "Retifanlimab is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ) anti–PD-1 monoclonal antibody with safety and clinical pharmacology that are characteristic for the class," wrote Giovanni Grignani, MD, a Medical Oncologist at the Candiolo Cancer Instit...

The FDA has approved pembrolizumab (Keytruda®, Merck) for adjuvant treatment of stage IB, II, or IIIA non–small cell lung cancer (NSCLC), following resection and platinum-based chemotherapy. "Although adjuvant chemotherapy improves overall survival in completely resected NSCLC, the absolute 5-year survival benefit is moderate compared with observation alone," wrote Mary O'Brien, MD, Head of Royal Marsden Hospital's Lung Unit, and colleagues, in their published results of the KEYNOTE-091 trial (N...

The FDA has approved a new indication for pafolacianine (Cytalux®, On Target Laboratories), a diagnostic agent, for the identification of lung cancer lesions in adult patients with known or suspected lung cancer who are undergoing surgery. Administered intravenously prior to surgery, pafolacianine is designed to locate additional hard-to-detect lung cancerous tissue. The safety and efficacy of pafolacianine were evaluated in the randomized, multicenter, open-label, phase 3 ELUCIDATE trial (NCT04...

The FDA has granted approval to dabrafenib (Tafinlar®, Novartis) with trametinib (Mekinist®, Novartis) for treatment of pediatric patients with BRAF V600E–mutated low-grade glioma (LGG) who require systemic therapy. In addition, the FDA approved new oral formulations of dabrafenib and trametinib for patients who cannot swallow pills. This is notable as it is the first approval of a systemic therapy in a first-line setting for pediatric patients with BRAF V600E–mutated LGG. "LGG is the most commo...

The FDA has granted approval to abemaciclib (Verzenio®, Eli Lilly and Company) with endocrine therapy—tamoxifen or an aromatase inhibitor—for treatment of adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer that is at a high risk of recurrence. Patients considered at high risk for recurrence include those with four or more pathologic axillary lymph nodes (pALN) or one to three pALN plus either a grade 3 t...

The FDA has granted approval to sacituzumab govitecan-hziy (Trodelvy®, Gilead Sciences, Inc.) for treatment of unresectable, locally advanced, or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer. Patients are required to have received at least one prior line of endocrine therapy and two systemic therapies in the metastatic setting. "Sacituzumab govitecan is a first-in-class trophoblast cell-surface antigen 2 (Trop-2)–directed antib...

The FDA has granted accelerated approval to tucatinib (Tukysa®, Seagen, Inc.) with trastuzumab for rat sarcoma (RAS) wild-type human epidermal growth factor receptor 2 (HER2)–positive unresectable or metastatic colorectal cancer (CRC) that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. "Patients with chemotherapy-refractory HER2-positive metastatic colorectal cancer receive limited clinical benefit with currently available therapies," said John Stric...

The FDA has granted accelerated approval to mosunetuzumab-axgb (Lunsumio™, Genentech) for adult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two lines of systemic therapy. "Mosunetuzumab is a CD20 x CD3 T-cell–engaging bispecific monoclonal antibody that redirects T cells to eliminate malignant B cells," wrote L. Elizabeth Budde, MD, PhD, Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of ...

The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin®, Ferring Pharmaceuticals) for treatment of high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Nadofaragene firadenovec-vncg is a non-replicating adenoviral vector-based gene therapy that cannot multiply in human cells and the first gene therapy to be approved for high-risk NMIBC. "BCG is the most effective therapy for h...

The FDA has granted accelerated approval to adagrasib (Krazati™, Mirati Therapeutics, Inc.) for treatment of adult patients with kirsten rat sarcoma viral oncogene homologue (KRAS) G12C–mutated locally advanced or metastatic non­–small cell lung cancer (NSCLC). Patients should have received one prior line of systemic therapy. Adagrasib is a rat sarcoma virus (RAS) guanosine triphosphatase (GTPase) family inhibitor. "Adagrasib (MRTX849), a potent, orally available, small molecule covalent inhibit...

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech, Inc.) for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients two years of age and older. Atezolizumab is an immune checkpoint inhibitor targeting programmed cell death ligand 1 (PD-L1). Safety and efficacy were measured in a phase 2, open-label, single-arm study (NCT03141684) which enrolled 49 patients with histologically or cytologically confirmed ASPS incurable by surgery and an Eastern Coop...

The FDA has granted approval to olutasidenib (Rezlidhia™, Rigel Pharmaceuticals Inc.) for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase 1 gene (IDH1) mutation. Additionally, the FDA granted approval to the Abbott RealTime IDH1 Assay to accurately detect and select patients to receive olutasidenib. Olutasidenib is an inhibitor specific to mutant IDH1. "Mutation of IDH1 occurs in 7% to 14% of patients with AML," wro...

The FDA has granted approval of cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for treatment of advanced non–small cell lung cancer (aNSCLC) with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) aberrations, and no prior systemic treatment. Cemiplimab-rwlc is a fully human immune checkpoint inhibitor targeting the programmed cell death receptor-1 (PD-1). "Pembrolizumab and ate...

The FDA has granted accelerated approval to teclistamab-cqyv (Tecvayli®, Janssen Biotech) for adult patients with relapsed/refractory multiple myeloma previously treated with four or more lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Teclistimab is the first bispecific B-cell maturation antigen (BCMA)–directed CD3 T-cell engager. "Standard treatment of multiple myeloma includes the administration of immunomodulatory agents, p...

The FDA has granted approval to tremelimumab (Imjudo®, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). "Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival," remarked Ghassan Abou-Alfa, MD, MBA, an Attending Physician at Memorial Sloan Kettering Cancer Center, and colleagues, regarding the HIMALAYA trial (NCT03298451), on which approval was ...