On 22 August 2024, Pfizer Canada announced that Padcev® (enfortumab vedotin) in combination with MSD’s Keytruda® (pembrolizumab) has been approved by Health Canada for treatment of unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior systemic therapy for mUC. The sponsor of Padcev® in Canada is Seagen Inc, which was acquired by Pfizer in December 2023.
This comes just days after the announcement by Astellas on 20 August 2024, that Padcev® was approved by China’s National Medical Products Administration (NMPA) for la/mUC after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.
Enfortumab vedotin, an antibody drug conjugate, is being co-developed by Astellas and Pfizer under a global development and commercialisation collaboration. Astellas and Pfizer co-promote Padcev® in the US. Pfizer holds commercialisation and regulatory responsibility in the Americas outside the US, while Astellas holds those responsibilities in ex-Americas jurisdictions.
Padcev® in combination with Keytruda® was approved in the US for la/mUC in December 2023. EMA’s CHMP adopted a positive opinion for the Padcev®/Keytruda® combination for first-line treatment of unresectable or metastatic urothelial carcinoma in July 2024.