AZN : FDA Okays IMFINZI Combination Regimen For Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

India, Nov. 13 -- AstraZeneca (AZN) has secured U.S. Food and Drug Administration approval for its immunotherapy IMFINZI (durvalumab) in combination with enfortumab vedotin-ejfv as a perioperative treatment for adult patients with muscle-invasive bladder cancer or MIBC who are ineligible for, or have declined, cisplatin-based chemotherapy.

The newly approved regimen consists of neoadjuvant treatment with IMFINZI and enfortumab vedotin-ejfv prior to radical cystectomy, followed by adjuvant IMFINZI monotherapy after surgery. The approval provides a new treatment option for patients with MIBC who previously had limited alternatives when cisplatin-based chemotherapy was not suitable.

The FDA granted approval following a Priority Review based ...