FDA Approvals

Results from the phase 1b/2 OrigAMI-4 trial supported FDA accelerated approval of subcutaneous amivantamab and hyaluronidase for previously treated recurrent or metastatic head and neck squamous cell carcinoma, introducing a dual...

Based on results from the phase 3 TALAPRO-3 trial, the FDA has approved talazoparib plus enzalutamide for patients with HRR-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, following a significant...

Based on results from the KEYNOTE-158 trial, the FDA converted pembrolizumab’s accelerated approval to traditional approval for adult and pediatric patients with previously treated unresectable or metastatic tumor mutational burden-high...

The FDA granted accelerated approval to dostarlimab for patients with stage II/III MSI-H/dMMR locally advanced rectal cancer, establishing an immunotherapy-based treatment option supported by sustained clinical complete responses and the...

The FDA expanded the indication for nogapendekin alfa inbakicept plus Bacillus Calmette-Guérin (BCG) to include patients with high-grade papillary-only, BCG-unresponsive non-muscle-invasive bladder cancer, extending treatment eligibility...

Based on results from the ATOMIC trial, the FDA has approved intravenous and subcutaneous atezolizumab in combination with fluoropyrimidine- and oxaliplatin-based chemotherapy for the adjuvant treatment of patients with stage III dMMR colon...

Based on results from the HER2CLIMB-05 trial, the FDA approved tucatinib plus trastuzumab and pertuzumab as maintenance treatment for HER2-positive advanced breast cancer following induction therapy, establishing a new maintenance option...

Based on results from BRUIN CLL-313, the FDA approved pirtobrutinib for previously untreated CLL/SLL without a known 17p deletion, establishing a first-line treatment option supported by a significant progression-free survival benefit over...

Based on results from the LITESPARK-011 trial, the FDA has approved belzutifan plus lenvatinib following PD-1 or PD-L1 inhibitor therapy for patients with advanced clear cell renal cell carcinoma, providing a new combination treatment option...

Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...