SGEN - Astellas and Seagen submit two approval requests for bladder cancer therapy

Astellas Pharma (ALPMF) and Seagen (SGEN) have completed the submissions of two supplemental Biologics License Applications for the bladder cancer therapy PADCEV (enfortumab vedotin-ejfv), co-developed by the two companies.The first submission seeking to convert PADCEV's accelerated approval to regular approval is backed by the phase 3 EV-301 trial.Supported by the Phase 3 EV-301 trial, the second submission requests a label expansion to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.Both applications will be reviewed by the FDA under the real-time oncology review (“RTOR”) pilot program, a more efficient process to speed up the review.Urothelial cancer is the most common type of bladder cancer. Under the accelerated approval program, the FDA authorized PADCEV in December 2019 for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

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Astellas and Seagen submit two approval requests for bladder cancer therapy