— Combination significantly improved disease-free survival in phase III trial
May 28, 2026
• 2 min read
The FDA approved durvalumab (Imfinzi) in combination with bacillus Calmette-Guérin (BCG) for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).
The approval was based on results from the phase III POTOMAC trial, which showed that adding the immune checkpoint inhibitor to BCG induction and maintenance therapy significantly improved disease-free survival (DFS) compared with BCG therapy alone (HR 0.68, 95% CI 0.50-0.93, P=0.015) in this patient population. Median DFS had not been reached in either arm.
