AstraZeneca PLC (NASDAQ:AZN) announced Friday that the US Food and Drug Administration has approved Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This is the first immunotherapy combination regimen approved in the US for this patient group.
The approval is based on results from the POTOMAC Phase III trial, which showed that adding Imfinzi to BCG induction and maintenance therapy reduced the risk of high-risk disease recurrence, progression, or death by 32% after one year compared to BCG alone. The trial data, with a median follow-up of more than five years, indicated an early and sustained disease-free survival benefit for patients receiving the combination treatment. The estimated median disease-free survival was not yet reached for either arm at the time of analysis.
The safety profile of Imfinzi plus BCG was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified. The addition of Imfinzi did not affect patients’ ability to complete BCG therapy and did not have a meaningful impact on patient-reported quality of life.
According to the company, more than 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 of treatment. The standard of care for these patients typically includes tumor resection followed by BCG instillation.
Regulatory submissions for Imfinzi in this indication are under review in the European Union, Japan, and several other countries.
Imfinzi is also approved in several countries for other forms of bladder cancer, as well as for certain lung, biliary tract, liver, gastric, and endometrial cancers.
This information is based on a press release statement from AstraZeneca’s SEC filing.
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