Posted by Michael Wonder on 11 Jul 2026
FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
10 July 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neo-adjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC).
This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.
