Merck Receives European Commission Approval For KEYTRUDA In Combination With Padcev For Adults With Resectable Muscle-Invasive Bladder Cancer
Key takeaways
- Merck’s KEYTRUDA‑Padcev combo gets EU approval, offering a new, chemotherapy‑free treatment for bladder cancer patients who cannot use cisplatin.
- 808 patients enrolled in KEYNOTE‑B15
- 405 patients received KEYTRUDA‑Padcev
- 403 patients received chemotherapy
What happened
The European Commission approved Merck’s KEYTRUDA (pembrolizumab) combined with Padcev (enfortumab vedotin‑ejfv) for adults with resectable muscle‑invasive bladder cancer, allowing the therapy to be used before and after surgery. This is the first PD‑1 inhibitor plus antibody‑drug conjugate regimen approved in the EU for this disease, regardless of cisplatin eligibility.
Why it matters
The approval expands a chemotherapy‑free treatment option for a large group of bladder cancer patients, including those who cannot tolerate cisplatin. It follows strong evidence from the Phase 3 KEYNOTE‑B15 trial showing significant improvements in event‑free survival, overall survival, and pathologic complete…
Short-term and longer-term
Short-term. In the next few weeks, European markets may react to the approval as it opens a new revenue stream for Merck’s oncology line.
Longer-term. Over the coming months, Merck’s oncology earnings could see a boost from the new KEYTRUDA‑Padcev indication, particularly as the drug enters multiple EU markets.