SGEN - FDA accepts Seagen Astellas' enfortumab vedotin applications in urothelial cancer

Under Real-Time Oncology Review ((RTOR)) pilot program, FDA has accepted for review Seagen (SGEN) and Astellas Pharma's (ALPMF) two supplemental Biologics License Applications (sBLA) for PADCEV (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer.The applications were granted Priority Review, with a target action date of August 17, 2021.RTOR allows the FDA review team to access key data before the company officially files its marketing application in order to quicken the review process. The review of both applications will also be conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.Project Orbis provides a framework for concurrent submission and review of oncology drugs among participating international partners. The first sBLA is based on the phase 3 EV-301 trial and seeks to convert PADCEV’s accelerated approval to regular approval.The second sBLA, based on cohort 2 of EV-201 trial, requests an expansion of the current indication to include patients with locally

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FDA accepts Seagen, Astellas' enfortumab vedotin applications in urothelial cancer