AstraZeneca's bid to expand durvalumab (Imfinzi) into high-risk non-muscle invasive bladder cancer has failed at the first attempt in the EU after the European Medicines Agency signaled it could not support a favorable benefit-risk conclusion, prompting the company to withdraw its variation application on June 24, 2026 before a formal negative Committee for Medicinal Products for Human Use opinion was issued.
The withdrawal covers a Type II variation application seeking to extend Imfinzi's existing EU marketing authorization — held by AstraZeneca AB since September 2018 — to include treatment of high-risk NMIBC in BCG-naïve patients, in combination with Bacillus Calmette-Guérin. The EMA said its provisional CHMP opinion was that the benefits of adding durvalumab to BCG did not outweigh the risks, prompting AstraZeneca to withdraw the application before a formal opinion was adopted.
The application was supported by the Phase III POTOMAC trial, which met its primary endpoint. Durvalumab plus BCG reduced the risk of high-risk disease recurrence, progression or death by 32% versus BCG alone (HR 0.68; p=0.0154), with an estimated 87% of patients remaining alive and disease-free at two years compared with 82% in the control arm. However, the CHMP concluded that the magnitude of benefit was of uncertain clinical relevance and did not outweigh the higher incidence of adverse events associated with durvalumab.
Because the application was withdrawn rather than formally refused, no European Commission decision will follow. The EMA has published a Q&A document (reference VR-0000289524) summarizing the CHMP's evaluation at the point of withdrawal; an assessment report will also be published given that the withdrawal occurred after completion of the first stage of evaluation. AstraZeneca has not disclosed any plans for resubmission or a supplementary data package.