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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