Accessibility Tools

Skip to main content

FDA Approvals

FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk Smoldering Multiple Myeloma
FDA Approvals
December 2025, Vol 2, No 11
On November 6, 2025, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma (SMM). Read More ›
FDA Approves Belantamab Mafodotin-blmf Combination Therapy for Relapsed or Refractory Multiple Myeloma
FDA Approvals
December 2025, Vol 2, No 11
On October 23, 2025, the FDA approved belanta-mab mafodotin-blmf (Blenrep) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. Read More ›
FDA Approves Revumenib for Relapsed or Refractory Acute Myeloid Leukemia With Susceptible NPM1 Mutation
FDA Approvals
December 2025, Vol 2, No 11
On October 24, 2025, the FDA approved revumenib (Revuforj) for the treatment of adult and pediatric patients aged 1 years and older with relapsed or refractory acute myeloid leukemia (AML) characterized by a susceptible nucleophosmin 1 (NPM1) mutation with no satisfactory alternative treatment options. Read More ›
FDA Approves Lurbinectedin and Atezolizumab Combination for Extensive-Stage Small Cell Lung Cancer
FDA Approvals
November 2025, Vol 2, No 10
On October 2, 2025, the FDA approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide. Read More ›
FDA Approves Imlunestrant for ESR1-Mutated Advanced Breast Cancer
FDA Approvals
November 2025, Vol 2, No 10
On September 25, 2025, the FDA approved imlunestrant (Inluriyo) for the treatment of advanced or metastatic breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and ESR1-mutated. Read More ›
FDA Approves Subcutaneous Formulation of Pembrolizumab (Keytruda Qlex) for Solid Tumors
FDA Approvals
November 2025, Vol 2, No 10
On September 19, 2025, the FDA approved pembrolizumab and berahyaluronidase alfapmph (Keytruda Qlex) for subcutaneous injection in adult and pediatric patients (12 years and older) with solid tumor indications previously approved for the intravenous formulation of pembrolizumab (Keytruda). Read More ›