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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