European Commission Gives Nod to Astellas and Seagen’s Padcev for Urothelial Cancer

European Commission Gives Nod to Astellas and Seagen’s Padcev for Urothelial Cancer

The European Commission has approved Astellas Pharma’s and Seagen’s antibody drug conjugate, Padcev (enfortumab vedotin), for the treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and a programmed death ligand-1 (PD-L1) or programmed death-1 (PD-1) inhibitor.

The approval was based on the results of a phase 3 trial in 608 participants. Those given the drug showed a significant overall survival benefit compared with participants who just received chemotherapy. The median overall survival in treated patients was 12.9 months compared with nine months for those who received chemotherapy alone.

Padcev received an accelerated approval from the FDA in December 2019 for the same indication. The agency granted full approval in July 2021.

Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.

April 20, 2022

https://www.fdanews.com/


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