FDA Approves AstraZeneca's IMFINZI With BCG for Non-Muscle-Invasive Bladder Cancer

U.S. regulators on May 29, 2026, approved AstraZeneca PLC’s (AZN) immunotherapy IMFINZI in combination with the standard-of-care Bacillus Calmette-Guérin (BCG) for adults with high-risk non-muscle-invasive bladder cancer. The Food and Drug Administration decision expands the label for the blockbuster anti-PD-L1 drug. The approval marks the first immunotherapy regimen cleared for this patient group, which faces high recurrence rates after BCG alone. IMFINZI plus BCG demonstrated a statistically significant improvement in event-free survival versus BCG monotherapy in a late-stage trial, AstraZeneca said. The regimen is expected to become a new standard in the setting. Bladder cancer is the ninth most common cancer globally. AstraZeneca shares edged higher in premarket trading following the announcement.