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Seagen : FDA Accepts Two SBLA For PADCEV In Locally Advanced Or Metastatic Urothelial Cancer

Seagen Inc. (SGEN) and Astellas Pharma Inc. said that the U.S. Food and Drug Administration has accepted two supplemental biologics license applications for padcev or 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.

The companies noted that the review of both applications will also be conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

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 the pivotal trial EV-201's cohort 2, requests an expansion of the current indication to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and are ineligible for cisplatin.

Health authorities in Australia and Canada will evaluate data from EV-301 and EV-201 for initial registrations under Project Orbis.

In March, the companies announced regulatory submissions in Japan and the European Union.

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