Merck’s cancer drug KEYTRUDA (pembrolizumab), combined with Padcev (enfortumab vedotin-ejfv), has received a positive recommendation from the European Medicines Agency’s CHMP for treating resectable muscle-invasive bladder cancer in adults ineligible for cisplatin-based chemotherapy. The regimen covers neoadjuvant therapy and post-surgery continued treatment. A final European Commission ruling is expected by Q3 2026. Phase 3 trial KEYNOTE-905 showed a 60% reduction in recurrence risk, a 50% reduction in death risk, and pathologic complete response rates of 57.1% versus 8.6% for surgery alone.
In-Depth:
Merck’s KEYTRUDA combo wins key EU backing for bladder cancer treatment
The decision now relocates to the European Commission, with a final ruling expected by the third quarter of 2026
Global pharma powerhoapply Merck has relocated a step closer to expanding its cancer portfolio in Europe.
This, after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommfinished apply of KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as a new bladder cancer treatment approach.
The recommfinishation covers apply as neoadjuvant therapy and continued treatment after radical cystectomy in adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
The decision now relocates to the European Commission, with a final ruling expected by the third quarter of 2026.
“Patients in Europe with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy have limited treatment options and are at high risk for disease recurrence,” stated Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
“This positive CHMP recommfinishation brings us closer to a new chapter of patient care – one that could address this significant unmet required by offering a KEYTRUDA-based regimen both before and after surgery, based on the compelling results from KEYNOTE-905.”
The CHMP decision is driven by Phase 3 KEYNOTE-905 (EV-303) trial results, run with Pfizer and Asinformas, which displayed strong benefits for the combination therapy over surgery alone.
The regimen delivered statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates.
The study displayed a 60% reduction in risk of EFS events, with median EFS not reached versus 15.7 months for surgery alone. It also cut the risk of death by 50%, with median overall survival not reached compared to 41.7 months in the control group. The pCR rate rose sharply to 57.1% versus 8.6%.
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