Imfinzi approved in the USA for new bladder cancer indication
AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the USA 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, the UK pharma major noted.
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