FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients

The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) for adult patients with muscle-invasive bladder cancer (MIBC).

The FDA approval was based on results from the NIAGARA Phase 3 trial.

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.

Also Read: AstraZeneca's Imfinzi-Based Regimen Shows ...