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.
Category: FDA Approvals
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.
ZEPZELCA® (Lurbinectedin)
The FDA on October 2, 2025, approved ZEPZELCA® in combination with Atezolizumab (TECENTRIQ®) or Atezolizumab and Hyaluronidase-tqjs (TECENTRIQ HYBREZA®) for the maintenance treatment of adult patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with TECENTRIQ® or TECENTRIQ HYBREZA®, Carboplatin, and Etoposide. ZEPZELCA® is a product of Jazz Pharmaceuticals, Inc. and TECENTRIQ® as well as TECENTRIQ HYBREZA® are products of Genentech Inc.
INLURIYO® (Imlunestrant)
The FDA on September 25, 2025, approved INLURIYO® , an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO® is a product of Eli Lilly and Company.
KEYTRUDA QLEX® (Pembrolizumab and Berahyaluronidase alfa-pmph)
The FDA on September 19, 2025, approved KEYTRUDA QLEX® (Pembrolizumab and Berahyaluronidase alfa-pmph) (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.