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MSD’s Keytruda® Plus Pfizer/Astellas’ Padcev® Approved in EU for Urothelial Carcinoma

Sep 3, 2024

On 3 September 2024, MSD announced that Keytruda® (pembrolizumab) plus Pfizer/Astellas antibody drug conjugate Padcev® (enfortumab vedotin-ejfv) was approved by the European Commission (EC) for the first line treatment of unresectable or metastatic urothelial carcinoma.  The EC approval follows the CHMP’s positive opinion in July 2024.

In December 2023, the US FDA approved Keytruda®/Padcev® for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.  In January 2024, Astellas announced that it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev®/Keytruda® for the same indication.

Enfortumab vedotin, an antibody drug conjugate, is being co-developed by Astellas and Pfizer under a global development and commercialisation collaboration.