Posted by Michael Wonder on 20 Dec 2022
Astellas, Seagen and Merck announce FDA acceptance of supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer
20 December 2022 - FDA granted the applications priority review with a PDUFA date of 21 April 2023.
Astellas, Seagen and Merck today announced the US FDA has accepted for priority review supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
