Industry News

FDA Approves Durvalumab for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

On November 25, the FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.
For more information, read the FDA announcement and the AstraZeneca press release.
Posted on 11/25/2025

FDA Approves Pembrolizumab With Enfortumab Vedotin-ejfv for Muscle Invasive Bladder Cancer

On November 21, the FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.
For more information, read the FDA announcement and the Merck press release.
Posted on 11/25/2025

FDA Grants Traditional Approval to Tarlatamab-dlle for Extensive Stage Small Cell Lung Cancer

On November 19, the FDA granted traditional approval to tarlatamab-dlle for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
For more information, read the FDA announcement and the Amgen press release.
Posted on 11/21/2025

FDA Grants Accelerated Approval to Sevabertinib for Non-squamous Non-small Cell Lung Cancer

On November 19, the FDA granted accelerated approval to sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
For more information, read the FDA announcement and the Bayer press release.
Posted on 11/21/2025

FDA Grants Traditional Approval to Daratumumab and Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis

On November 19, the FDA granted traditional approval to daratumumab and hyaluronidase-fihj with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis.
For more information, read the FDA announcement and visit the Janssen Biotech website.
Posted on 11/21/2025

FDA Approves Selumetinib for Select Adults With Neurofibromatosis Type 1

On November 19, the FDA approved selumetinib for adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
For more information, read the FDA announcement and the AstraZeneca press release.
Posted on 11/21/2025

FDA Approves Epcoritamab-bysp for Follicular Lymphoma Indications

On November 18, the FDA approved epcoritamab-bysp with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after 2 or more lines of systemic therapy.
For more information, read the FDA announcement and the Genmab press release.
Posted on 11/18/2025

FDA Approves New Interchangeable Biosimilar to Perjeta

On November 13, the FDA approved pertuzumab-dpzb as an interchangeable biosimilar to pertuzumab. This is the first approval of a biosimilar for pertuzumab.
For more information, read the FDA announcement and visit the Shanghai Henlius Biologics website.
Posted on 11/14/2025

FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukemia With a NPM1 Mutation

On November 13, the FDA approved ziftomenib, a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options.
For more information, read the FDA announcement and the Kura Oncology press release.
Posted on 11/14/2025

FDA Approves Daratumumab and Hyaluronidase-fihj for High-risk Smoldering Multiple Myeloma

On November 6, the FDA approved daratumumab and hyaluronidase-fihj for adults with high-risk smoldering multiple myeloma.
For more information, read the FDA announcement and the Janssen Biotech press release.
Posted on 11/7/2025