Industry News

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

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

On October 24, the FDA approved revumenib, a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
For more information, read the FDA announcement and the Syndax Pharmaceuticals press release.
Posted on 10/27/2025

FDA Approves Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma

On October 23, the FDA approved belantamab mafodotin-blmf, a B-cell maturation antigen-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
For more information, read the FDA announcement and the GlaxoSmithKline press release.
Posted on 10/27/2025