Longevity & Aging

FDA Approves Durvalumab Plus BCG to Cut Bladder Cancer Recurrence Risk by 32%

The FDA has approved durvalumab (IMFINZI) combined with BCG therapy for adults with high-risk, non-muscle-invasive bladder cancer who have not previously received BCG. The decision follows the Phase III POTOMAC trial, which showed adding one year of durvalumab to standard BCG reduced the risk of disease recurrence, progression, or death by 32% compared to BCG alone. With over five years of follow-up, the benefit appeared early and was sustained, and median disease-free survival had not yet been reached. Safety profiles were consistent with known risks, quality of life was preserved, and patients were still able to complete their BCG course — a meaningful outcome for over 31,000 Americans treated annually for this condition.