Posted by Michael Wonder on 19 Apr 2021
Seagen and Astellas announce U.S. FDA acceptance of two supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
19 April 2021 - Australia and Canada regulators will review applications as part of FDA’s Project Orbis.
Seagen and Astellas Pharma today announced the U.S. FDA filed two supplemental biologics license application submissions for Padcev (enfortumab vedotin-ejfv) for review as part of the Real-Time Oncology Review pilot program.
The applications were granted priority review, with a target action date of 17 August 2021.
