The FDA on November 25, 2025, approved IMFINZI® with Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI®, for adults with resectable Gastric or GastroEsophageal Junction adenocarcinoma (GC/GEJC). IMFINZI® is a product of AstraZeneca.
Author: RR
KEYTRUDA® or KEYTRUDA QLEX® with PADCEV®
The FDA on November 21, 2025, approved KEYTRUDA® (Pembrolizumab) or KEYTRUDA QLEX® (Pembrolizumab and Berahyaluronidase alfa-pmph) with PADCEV® (Enfortumab vedotin-ejfv) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with Muscle Invasive Bladder Cancer (MIBC) who are ineligible for Cisplatin. KEYTRUDA® and KEYTRUDA QLEX® are products of Merck and PADCEV® is a product of Astellas Pharma.
IMDELLTRA® (Tarlatamab-dlle)
The FDA on November 19, 2025, granted traditional approval to IMDELLTRA® for adults with Extensive Stage Small Cell Lung Cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA® received accelerated approval for this indication in 2024. IMDELLTRA® is a product of Amgen Inc.
HYRNUO® (Sevabertinib)
The FDA on November 19, 2025, granted accelerated approval to HYRNUO®, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) Tyrosine Kinase Domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. HYRNUO® is a product of Bayer HealthCare Pharmaceuticals Inc.
DARZALEX FASPRO® (Daratumumab and Hyaluronidase-fihj)
The FDA on November 19, 2025, granted traditional approval to DARZALEX FASPRO® with Bortezomib, Cyclophosphamide, and Dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. DARZALEX FASPRO® is a product of Janssen Biotech Inc.
KOSELUGO® (Selumetinib)
The FDA on November 19, 2025, approved KOSELUGO® for adults with NeuroFibromatosis type 1 (NF1) who have symptomatic, inoperable Plexiform Neurofibromas (PN). FDA previously approved KOSELUGO® capsules and granules for pediatric patients 1 year of age and older for this indication. KOSELUGO® is a product of AstraZeneca Pharmaceuticals LP.
EPKINLY® (Epcoritamab-bysp)
The FDA on November 18, 2025, approved EPKINLY® with Lenalidomide and Rituximab for relapsed or refractory Follicular Lymphoma (FL). The FDA also granted traditional approval to EPKINLY® as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (EPKINLY® was granted accelerated approval for this indication in 2024). Epkinly is a product of Genmab US, Inc.
POHERDY® (Pertuzumab-dpzb)
The FDA on November 13, 2025, approved POHERDY® as an interchangeable biosimilar to PERJETA® (Pertuzumab). This is the first approval of a biosimilar for PERJETA®. POHERDY® is a product of Shanghai Henlius Biologics Co. Ltd. and PERJETA® is a product of Genentech Inc.
KOMZIFTI® (Ziftomenib)
The FDA on November 13, 2025, approved KOMZIFTI®, a menin inhibitor, for adults with relapsed or refractory Acute Myeloid Leukemia (AML) with a susceptible Nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. KOMZIFTI® is a product of Kura Oncology, Inc.
DARZALEX FASPRO® (Daratumumab and hyaluronidase-fihj)
The FDA on November 6, 2025, approved DARZALEX FASPRO® for adults with high-risk Smoldering Multiple Myeloma (SMM). DARZALEX FASPRO® is a product of Janssen Biotech, Inc.