Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advanced Bladder Cancer
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- The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety
- The results depicted that the study met its dual 1EPs with a mOS of 31.5mos. vs 16.1mos. (reducing the risk of death by 53%) & mPFS of 12.5mos. vs 6.3mos. (reducing the risk of death by 55%). The results were presented at ESMO 2023
- Padcev is an ADC developed to function against Nectin-4, the protein located on the surface of cells expressed in bladder cancer. The combination of Padcev + Keytruda was approved by the US FDA in Dec 2023
Ref: Astellas | Image: Astellas
Related News:- Astellas Reports the Submission of sNDA to the Japan MHLW for Padcev in Combination with Keytruda to Treat Advanced Bladder 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.
