IMFINZI® (durvalumab) approved in the US in first and only immunotherapy combination for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer
Based on POTOMAC Phase III trial results which showed a 32% reduction in the risk of high-risk disease recurrence, progression or death after one year of IMFINZI added to BCG vs. BCG alone
AstraZeneca’s IMFINZI® (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).
The approval by the Food and Drug Administration (FDA) is based on positive results from the POTOMAC Phase III trial which were presented at the European Society for Medical Oncology (ESMO) Congress 2025 and simultaneously published in The Lancet.
In 2024, over 31,000 people in the US were treated for high-risk NMIBC, a curative-intent setting where the standard of care is tumor resection followed by BCG treatment directly into the bladder.1,2 About half of patients with NMIBC are at high-risk for disease recurrence or progression based on certain characteristics of their cancer, such as tumor grade, stage and specific tumor features.3 Up to 80% of high-risk patients experience disease recurrence within five years of treatment.3,4
