Astellas and Pfizer Report the NMPA’s Acceptance of sBLA for Enfortumab Vedotin Plus Keytruda for Treating 1L Bladder Cancer
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- Astellas’ sBLA of enfortumab vedotin + Keytruda as a 1L treatment of locally advanced/metastatic urothelial cancer (la/mUC) patients who are treatment naïve has been accepted by the NMPA on Mar 27, 2024
- The sBLA was supported by the P-III (EV-302) study assessing enfortumab vedotin + Keytruda vs Pt-based CT in patients (n=886) with previously untreated la/mUC demonstrating improved OS & PFS
- Moreover, enfortumab vedotin is under review with the NMPA as a treatment of locally advanced or metastatic la/mUC patients who were on PD-1/L1 therapy and Pt-based CT, the EMA’s CHMP & Japan’s MHLW are reviewing enfortumab vedotin + Keytruda and in Dec 2023, the US FDA has approved the combination
Ref: Astellas | Image: Astellas
Related News:- Astellas and Seagen Report the NMPA’s Acceptance of BLA for Enfortumab Vedotin to Treat Urothelial 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.
