Bagrat Lalayan Joins AstraZeneca as Franchise Head, US Medical Affairs, Breast Cancer

AstraZeneca (AZN) received FDA Priority Review for IMFINZI plus enfortumab vedotin to treat muscle-invasive bladder cancer. The application follows Phase III VOLGA trial results showing improved survival rates. The FDA decision is expected in Q4 2026, with reviews ongoing in other regions.

The FDA granted Priority Review to AstraZeneca's combination therapy of IMFINZI and enfortumab vedotin for muscle-invasive bladder cancer. The decision is based on the VOLGA Phase III trial, which showed significant improvements in event-free and overall survival. If approved, the regimen could become a new standard of care, with a regulatory decision expected in Q4 2026.

AstraZeneca has registered a new hypertension drug, Baxfendy, in Russia. The drug is approved as an adjunctive therapy for patients not achieving sufficient blood pressure reduction with three or more medications, according to the company's medical director in Russia and Eurasia.

AstraZeneca announced the FDA granted priority review for Imfinzi (durvalumab) combined with enfortumab vedotin to treat muscle-invasive bladder cancer in patients ineligible for cisplatin chemotherapy. The company expects a decision by Q4 2026. AstraZeneca shares rose 1.4% to 12,568 pence in London. According to the company, approval could set a new standard of care.

AstraZeneca's application for Imfinzi (durvalumab) with enfortumab vedotin to treat muscle-invasive bladder cancer has been granted priority review by the FDA. The drugmaker cited significant improvements in survival rates from the Phase III VOLGA trial. A decision is expected in Q4 2026, potentially offering a new standard of care for patients ineligible for cisplatin-based chemotherapy.

AstraZeneca's supplemental Biologics License Application (sBLA) for Imfinzi plus EV received priority review status in the US for muscle-invasive bladder cancer (MIBC). According to the company, this designation is granted to medicines that offer significant improvements in safety or efficacy. The decision is based on positive results from a Phase III trial.