Astellas & Seagen Reports the US FDA’s Acceptance of sBLA with Priority Review for Padcev (enfortumab vedotin-ejfv) + Keytruda to Treat Urothelial Cancer
Shots:
- The sBLA was accepted based on the results from the P-III (EV-302/KEYNOTE-A39) trial evaluating the Padcev + Keytruda vs CT on locally advanced or metastatic urothelial cancer (la/mUC) (n=886). The application also received priority review with an expected PDUFA date of May 9, 2024
- The dual 1EP of the study showed statistically significant & clinically meaningful results with an improved OS of 31.5 vs 16.1mos. & median PFS of 12.5 vs 6.3mos., additionaly, 2EPs results showed 68% vs 44% confirmed ORR & mDoR was not reached vs 7mos. in CT. Moreover, 29.1% showed a complete response & 38.4% experienced a partial response
- Padcev (enfortumab vedotin-ejfv) is an ADC targeting Nectin-4, a protein highly expressed in bladder cancer on cell surfaces
Ref: PR Newswire | Image: Astellas
Related News:- Seagen and Astellas Report P-III Trial (EV-302) Results of Padcev (enfortumab vedotin-ejfv) and Keytruda for Advanced Bladder Cancer
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
