AstraZeneca Reports the US FDA’s sBLA Acceptance and Priority Review of Imfinzi to Treat Muscle-Invasive Bladder Cancer
Shots:
- The US FDA has accepted & granted priority review to sBLA of Imfinzi for treating muscle-invasive bladder cancer (MIBC), with decision anticipated in Q2’25. Further submissions are under review across the EU, Japan & other regions
- sBLA was based on P-III (NIAGARA) study assessing perioperative Imfinzi + neoadj. CT followed by Imfinzi adj. vs CT alone treatment in patients (n=1,063) with MIBC, with data presented at ESMO 2024 & published in the NEJM
- Interim analysis showed reduced disease progression, recurrence, or death risk by 32% (mEFS: not reached vs 46.1mos.), 67.8% vs 59.8% were event free at 2yrs. Imfinzi also reduced death risk by 25% (mOS not reached), 82.2% vs 75.2% were alive at 2yrs.
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca’s Imfinzi (Durvalumab) Secures the US FDA’s Approval for Treating Limited-Stage Small Cell Lung Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
