Posted by Michael Wonder on 18 Feb 2021
Astellas and Seagen announce submission of two supplemental biologics license applications to the U.S. FDA for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
18 February 2021 - Submissions will be reviewed under Real-Time Oncology Review based on clinical trials EV-301 and cohort 2 of EV-201.
Astellas and Seagen today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. FDA for Padcev (enfortumab vedotin-ejfv).
One submission, based on the phase 3 EV-301 trial, seeks to convert Padcev's accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201's second cohort, requests an expansion of the current label 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.
