On November 30, 2023, Astellas Pharma Inc. and Seagen Inc. revealed in a release that the FDA has accepted their supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) for priority review.
This application aims to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a type of bladder cancer that has spread to nearby tissues or other areas of the body.
The FDA, as part of the Prescription Drug User Fee Act (PDUFA), has scheduled a target action date of May 9, 2024, for the review of this application.
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development at Astellas, expressed anticipation for the FDA’s review. He highlighted that if approved, it would extend the accelerated approval of the combination therapy from the EV-103 study to standard approval.
It would benefit all first-line locally advanced or metastatic urothelial cancer patients, including those eligible for cisplatin.
Seagen’s President of Research and Development, Roger Dansey, highlighted the significant impact of pairing enfortumab vedotin with pembrolizumab for advanced bladder cancer.
He emphasized the FDA’s acceptance of their application as a pivotal move toward providing this vital combination to patients lacking treatment options at an advanced stage.
Source: FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
https://newsroom.astellas.us/2023-11-30-FDA-Grants-Priority-Review-for-Supplemental-Biologics-License-Application-sBLA-of-PADCEV-R-enfortumab-vedotin-ejfv-with-KEYTRUDA-R-pembrolizumab-for-First-Line-Treatment-of-Advanced-Bladder-Cancer
