(RTTNews) - AstraZeneca plc (AZN) announced that the U.S. FDA has accepted and granted Priority Review to its supplemental Biologics License Application for IMFINZI in combination with enfortumab vedotin (EV) for the treatment of patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy.
Muscle-invasive bladder cancer (MIBC) occurs when the tumor grows into the muscle layer of the bladder wall. Approximately one in four bladder cancer patients develops this form of the disease. Many patients are unable to receive cisplatin-based chemotherapy due to kidney problems or other health conditions, leaving them with limited treatment options. Historically, surgery to remove the bladder has been the standard approach, but recurrence rates remain high and long-term outcomes can be poor.
The FDA grants Priority Review to therapies that could offer meaningful improvements over existing treatment options. The agency's decision on the application is expected during the fourth quarter of 2026 under the Prescription Drug User Fee Act process.
The filing is supported by results from the Phase 3 VOLGA trial. In a planned interim analysis, perioperative treatment with IMFINZI combined with neoadjuvant enfortumab vedotin achieved statistically significant and clinically meaningful improvements in event-free survival and overall survival compared with radical cystectomy, with or without approved adjuvant treatment. Event-free survival measures the length of time patients remain free from disease recurrence, progression, or other defined events following treatment.
The regimen is administered around the time of surgery, with enfortumab vedotin given before bladder removal surgery as part of the treatment strategy. According to AstraZeneca, if approved, the combination could become the first perioperative regimen using enfortumab vedotin only before surgery for this patient population.
The company reported that the safety and tolerability profile of IMFINZI plus enfortumab vedotin was consistent with the known safety profiles of the individual therapies, and no new safety signals were identified during the study.
IMFINZI is AstraZeneca's immunotherapy that works by helping the immune system recognize and attack cancer cells. The company continues to evaluate the therapy across multiple cancer types and treatment settings as it seeks to expand its oncology profile.
AZN has traded between $146.66 and $212.71 over the past year. The stock closed Thursday's trading at $164.56, up 0.75%. In pre-market trading the stock is at $165.03, up 0.29%.