FDA Approvals

On January 27, 2026, the FDA granted approval to daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients with newly diagnosed multiple myeloma who are ineligible for autologous...

On December 17, 2025, the FDA approved a subcutaneous formulation of amivantamab and hyaluronidase-lpuj for adult patients across all indications previously approved for intravenous amivantamab.

Based on results from the TRITON3 study, the FDA granted approval to rucaparib for previously treated patients with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer.

On December 15, 2025, the FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the frontline treatment of patients with unresectable or metastatic HER2-positive breast cancer as assessed by an FDA-approved test.

On December 12, 2025, the FDA granted approval to niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as assessed by an...

On December 4, 2025, the FDA has approved lisocabtagene maraleucel for adult patients with relapsed/refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.

Based on results from the BRUIN-CLL-321 study, the FDA granted traditional approval to pirtobrutinib for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a BTK inhibitor.

On November 21, 2025, the FDA granted approval to pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for patients with muscle...

Based on results from the phase 3 DeLLphi-304 trial, the FDA has approved tarlatamab for the treatment of patients with extensive-stage small cell lung cancer who experience disease progression on or after platinum-based chemotherapy.

The FDA has granted accelerated approval to sevabertinib for adults with locally advanced or metastatic non-squamous non–small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations who have received prior systemic...