WILMINGTON, DE — AstraZeneca has secured U.S. regulatory approval for IMFINZI (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) therapy for adults with previously untreated high-risk non-muscle-invasive bladder cancer, expanding the drug’s use into an earlier stage of the disease where recurrence rates remain high.
The U.S. Food and Drug Administration approval is based on results from the Phase III POTOMAC trial, which found that adding IMFINZI to standard BCG induction and maintenance therapy reduced the risk of disease recurrence, progression or death by 32% compared with BCG treatment alone.
The decision gives physicians a new treatment option for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC), a setting in which treatment standards have remained largely unchanged for decades despite frequent disease recurrence.
More than 31,000 patients in the United States were treated for high-risk NMIBC in 2024, according to information provided by the company. While tumors in this form of bladder cancer have not invaded the bladder muscle, patients remain at substantial risk of recurrence and progression. AstraZeneca said up to 80% of high-risk patients experience disease recurrence within five years.
“The durvalumab plus BCG regimen is the first new therapy approved in over 30 years for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer,” said Dr. Neal Shore, co-principal investigator of the POTOMAC trial and director of START Carolinas. He added that the regimen reduced the risk of recurrence, progression or death by “almost a third” compared with BCG alone.
The POTOMAC study showed a disease-free survival hazard ratio of 0.68, meeting its primary endpoint with statistical significance. The benefit emerged within four months of treatment initiation and was maintained through a median follow-up period exceeding five years.
AstraZeneca reported that the safety profile of the combination was consistent with the known effects of IMFINZI and BCG, with no new safety concerns identified. The company also said the addition of IMFINZI did not interfere with patients’ ability to complete BCG treatment and had no meaningful effect on reported quality of life.
The approval further strengthens AstraZeneca’s position in the bladder cancer market, where the company is pursuing multiple indications for IMFINZI across early-stage and advanced disease settings.
Regulatory applications based on the POTOMAC data remain under review in the European Union, Japan and several other markets.
Separately, AstraZeneca recently reported positive Phase III results from the VOLGA trial in muscle-invasive bladder cancer and continues evaluating IMFINZI in advanced disease through the Phase III NILE study.
IMFINZI is already approved in multiple countries for certain patients with muscle-invasive bladder cancer based on findings from the Phase III NIAGARA trial.
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