FDA Approvals

Based on results from the SWOG 1826 trial, the FDA has approved nivolumab plus doxorubicin, vinblastine, and dacarbazine for previously untreated patients with advanced classical Hodgkin lymphoma.

Based on results from the phase 3 MajesTEC-3 trial, the FDA approved teclistamab plus daratumumab hyaluronidase for previously treated patients with relapsed or refractory multiple myeloma.

Based on results from the Beamion LUNG-1 trial, the FDA has approved zongertinib for patients with HER2-mutated unresectable or metastatic non-squamous non-small cell lung cancer.

On February 24, 2026, the FDA granted traditional approval to frontline encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for patients with metastatic colorectal cancer harboring a BRAF V600E mutation, as detected...

Based on results from the phase 3 AMPLIFY trial, the FDA has approved acalabrutinib plus venetoclax for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA has approved a new, simplified once-monthly dosing schedule for amivantamab plus hyaluronidase when administered in combination with lazertinib for the first-line treatment of EGFR-mutated advanced non-small cell lung cancer.

The FDA has approved Optune Pax® in combination with gemcitabine and nab-paclitaxel for adults with locally advanced pancreatic cancer based on phase 3 PANOVA-3 results showing a statistically significant improvement in overall survival and...

On February 10, 2026, the FDA approved pembrolizumab and pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for patients with PD-L1-positive, platinum-resistant epithelial ovarian,...

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.