AstraZeneca Gets FDA Priority Review for IMFINZI Combo

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.

AstraZeneca (AZN) reported that its Phase III SERENA-4 trial for camizestrant in breast cancer failed to meet the primary endpoint, limiting its market potential. The company's broader oncology portfolio and precision-medicine strategy remain intact, with other trials and established drugs supporting growth.