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News
The EU's drug advisory committee has recommended approving pembrolizumab (Keytruda) plus enfortumab vedotin (Padcev) as perioperative treatment for resectable muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. The recommendation follows strong phase 3 KEYNOTE-B15/EV-304 trial data showing a 47% reduction in disease progression or death and a 55.8% pathologic complete response rate vs. 32.5% with standard chemotherapy. The FDA had already approved the regimen in July 2026.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of pembrolizumab (Keytruda) plus enfortumab vedotin (Padcev) as perioperative therapy — meaning both before and after surgery — for adults with resectable muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. The recommendation also covers the subcutaneous formulation of pembrolizumab. If formally approved, this would be the first PD-1 inhibitor plus antibody-drug conjugate regimen authorized in the EU for MIBC.
The CHMP's decision is backed by the phase 3 KEYNOTE-B15/EV-304 trial, which enrolled 808 cisplatin-eligible MIBC patients and compared perioperative pembrolizumab plus enfortumab vedotin against standard neoadjuvant gemcitabine/cisplatin chemotherapy followed by surgery. The combination delivered improvements across every key endpoint — mirroring the FDA's July 2026 approval of the same regimen for all MIBC patients eligible for cystectomy, regardless of cisplatin eligibility.
By the Numbers:
Why it matters: Up to half of MIBC patients cannot tolerate cisplatin-based chemotherapy, leaving them with limited options. This chemo-free regimen now offers a highly effective alternative for a broader patient population — and its dual regulatory backing on both sides of the Atlantic signals a likely shift in the standard of care for MIBC globally.
