Shots:
- The US FDA has approved AZ‘s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan
- Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapy
- Trial showed a 32% reduction in the risk of high-risk disease recurrence, progression, or death, delivering early & sustained DFS benefit starting less than 4mos. after starting therapy over a mFU of 60.7mos., with median DFS not yet reached in either arm; data were published in The Lancet
Ref: Businesswire | Image: AstraZeneca | Press Release
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