FDA Approves New Combination Therapy for Bladder Cancer

The FDA has approved a new combination treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have refused cisplatin-based chemotherapy. The regimen involves durvalumab (Imfinzi) combined with enfortumab vedotin-ejfv (Padcev) as neoadjuvant therapy, followed by single-agent durvalumab after radical cystectomy. This decision, supported by data from the Phase 3 VOLGA trial, provides an additional treatment option for a specific population facing this aggressive cancer.