Key Takeaways:
The FDA on Thursday approved AstraZeneca's Imfinzi (durvalumab) with BCG for high-risk non-muscle-invasive bladder cancer, the first immunotherapy combo in the setting in over 30 years.
"The durvalumab plus BCG regimen is the first new therapy approved in over 30 years for patients with BCG-naive, high-risk non-muscle-invasive bladder cancer," Neal Shore, director of START Carolinas and co-principal investigator in the trial, said. "Unfortunately, many of these patients experience disease recurrence requiring repeated surgical procedures, as well as disease progression resulting in surgical removal of their bladder."
The approval is based on the Phase III POTOMAC trial, which showed adding one year of Imfinzi to BCG induction and maintenance therapy reduced the risk of disease recurrence, progression or death by 32% compared with BCG alone (HR 0.68; 95% CI 0.50-0.93; P=0.0154). With a median follow-up exceeding five years (60.7 months), the benefit emerged within four months of starting treatment. Median disease-free survival was not reached in either arm.
About 31,000 people in the US were treated for high-risk NMIBC in 2024, and up to 80% of high-risk patients experience disease recurrence within five years. The approval marks a shift in standard of care for patients who have not previously received BCG, a population that has had no new treatment options for three decades. Regulatory submissions based on the POTOMAC results are under review in the European Union, Japan and several other countries.
The approval strengthens AstraZeneca's position in bladder cancer, where Imfinzi generated $6.1 billion in sales in 2025, up 37% year over year. The company recently reported positive results from the VOLGA trial testing perioperative Imfinzi plus enfortumab vedotin in muscle-invasive bladder cancer. Investors will watch for the pace of adoption in the BCG-naive NMIBC setting and for regulatory decisions in ex-US markets.
This article is for informational purposes only and does not constitute investment advice.
