EU approves Merck’s KEYTRUDA-Padcev bladder cancer regimen
- Merck (NYSE:MRK) announced European Commission approval of KEYTRUDA plus Padcev as treatment before and after surgery for adults with resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility.
- In the KEYNOTE-B15 trial involving cisplatin-eligible patients, the combination reduced the relative risk of event-free survival events by 47% and death by 35% compared with chemotherapy followed by surgery.
- The authorization builds on the EU's June 2026 approval for cisplatin-ineligible patients, while commercial availability will depend on country-specific reimbursement procedures.
Merck (NYSE:MRK) announced European Commission approval of KEYTRUDA plus Padcev for adults with resectable muscle-invasive bladder cancer, regardless of eligibility for cisplatin-based chemotherapy.
The authorization covers treatment before radical cystectomy and continued treatment afterward, expanding an earlier European approval restricted to cisplatin-ineligible patients.
The decision follows September's positive regulatory recommendation and Phase 3 KEYNOTE-B15 results from a trial conducted with Pfizer and Astellas.
KEYNOTE-B15 showed a 47% reduction in the relative risk of disease progression, recurrence or death among cisplatin-eligible patients receiving the combination.
The regimen also reduced the relative risk of death by 35%, while pathologic complete response rates reached 55.8%, compared with 32.5% for chemotherapy.
The expanded authorization includes KEYTRUDA SC and covers the European Union's 27 member states, with availability in individual countries dependent on reimbursement arrangements.
The decision broadens Merck's perioperative bladder cancer treatment portfolio, following previous U.S. approval and the June European authorization for cisplatin-ineligible patients.
