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Posted 25 November 2025 AM
A "practice-changing" combo is the first to get FDA approval for certain types of bladder cancer, with the approval coming months earlier than the pharmas involved anticipated.
The FDA has approved MSD's PD-1 inhibitor Keytruda and Keytruda Qlex, each in combination with Astellas' antibody-drug conjugate Padcev, as neoadjuvant treatment and then continued after surgery as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

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