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.
Category: FDA Approvals
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.
REVUFORJ® (Revumenib)
The FDA on October 24, 2025, approved REVUFORJ®, a menin inhibitor, for relapsed or refractory Acute Myeloid Leukemia with a susceptible Nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. REVUFORJ® is a product of Syndax Pharmaceuticals, Inc.
BLENREP® (Belantamab mafodotin-blmf)
The FDA on October 23, 2025, approved BLENREP®, a B-Cell Maturation Antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with Bortezomib and Dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. BLENREP® is a product of GlaxoSmithKline.
LIBTAYO® (Cemiplimab-rwlc)
The FDA on October 8, 2025, approved LIBTAYO® for the adjuvant treatment of adults with Cutaneous Squamous Cell Carcinoma (CSCC) at high risk of recurrence after surgery and radiation. LIBTAYO® is a product of Regeneron Pharmaceuticals Inc.