European Commission approves Keytruda plus Padcev for perioperative treatment of muscle-invasive bladder cancer

The European Commission has authorised Keytruda plus Padcev before and after surgery for adults with resectable muscle-invasive bladder cancer, expanding perioperative treatment options in the EU.

Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) are approved as neoadjuvant treatment before radical cystectomy followed by adjuvant treatment for adults with resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility.

In the Phase III KEYNOTE-B15 study involving cisplatin-eligible patients, the combination reduced the risk of disease progression, recurrence or death by 47% and the risk of death by 35% compared with neoadjuvant gemcitabine-cisplatin and surgery.

Field	Content
Article Type	Approvals
Regulatory Authority	European Commission
Regulatory Decision	Marketing authorisation
Company	Merck & Co.; Padcev development and commercialisation partners not specified in supplied summary
Drug Combination	Keytruda plus Padcev
Drug Names	Pembrolizumab; enfortumab vedotin
Therapeutic Area	Oncology; bladder cancer
Approved Indication	Perioperative treatment of adults with resectable muscle-invasive bladder cancer
Patient Population	Adults with resectable muscle-invasive bladder cancer regardless of cisplatin eligibility
Treatment Sequence	Neoadjuvant Keytruda plus Padcev before radical cystectomy followed by adjuvant treatment
Supporting Study	Phase III KEYNOTE-B15
Study Comparison	Combination regimen versus neoadjuvant gemcitabine-cisplatin and surgery
Study Population	Cisplatin-eligible patients
Progression Recurrence or Death Risk Reduction	47% relative risk reduction
Overall Survival Risk Reduction	35% relative reduction in risk of death
Geography	European Union
Announcement Date	21 October 2026
What Happened	The European Commission authorised perioperative Keytruda plus Padcev for adults with resectable muscle-invasive bladder cancer.
Why It Matters	The approval expands access to an immunotherapy and antibody-drug conjugate combination in the potentially curative treatment setting.
Clinical Evidence	KEYNOTE-B15 reported improved disease-related and survival outcomes against a chemotherapy-based comparator in cisplatin-eligible patients.
Key Takeaway	The new EU authorisation covers perioperative treatment regardless of cisplatin eligibility; the supplied efficacy figures come from a cisplatin-eligible trial population.
What to Watch	European reimbursement decisions, clinical guideline adoption, treatment uptake and longer-term outcomes.
Primary Source	Merck & Co.
Primary Source URL	https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-cancer-mibc/
Relevant Date	21 October 2026

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