The sNDA was submitted based on the results from the P-III (EV-302) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT as a 1L treatment of previously untreated patients (n=886) with locally advanced or metastatic urothelial cancer. The dual 1EP of the study were OS & PFS & 2EP were ORR, DoR & safety
As per the results the combination therapy depicted a statistically significant & clinically meaningful improvement in OS & PFS vs platinum-containing CT whereas the safety results were consistent with the previously reported study results analysing the combination therapy
The company had submitted the sNDA to MHLW in Jan 2024. Moreover, the CHMP is also reviewing the combination therapy while the US FDA has granted approval to the therapy 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
