Key insights
- The European Medicines Agency recommended approval of Merck's Keytruda with Padcev for bladder cancer, mirroring a prior FDA approval. While positive for Merck, the direct impact on the broader US equity market is limited, but it reinforces positive sentiment towards the healthcare sector and Merck's growth prospects.
RAHWAY, N.J. - The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Merck’s (NYSE:MRK) Keytruda in combination with Padcev for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy, according to a press release statement. The pharmaceutical giant, with a market capitalization of $286.2 billion, has seen its shares surge 54% over the past year.
The recommendation covers both Keytruda and Keytruda SC as neoadjuvant treatment before radical cystectomy and continued as adjuvant treatment after surgery. The European Commission will review the recommendation for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected by the third quarter of 2026.
The opinion is based on results from the Phase 3 KEYNOTE-905 trial, conducted in collaboration with Pfizer and Astellas. The study showed the combination reduced the risk of event-free survival events by 60% compared to surgery alone. Median event-free survival was not reached for the combination versus 15.7 months for surgery alone.
The regimen also reduced the risk of death by 50% versus surgery alone. Median overall survival was not reached for the combination compared to 41.7 months for surgery alone. The trial demonstrated a pathologic complete response rate of 57.1% versus 8.6% for surgery alone.According to InvestingPro analysis, Merck currently trades below its Fair Value, appearing on the platform’s Most Undervalued list. For deeper insights into Merck’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available for MRK and 1,400+ other US equities.
The U.S. Food and Drug Administration approved Keytruda and Keytruda QLEX in combination with Padcev for this indication in November 2025.
According to the press release, approximately 224,700 patients were diagnosed with bladder cancer in Europe in 2022, with more than 70,300 deaths from the disease. About 25% of newly diagnosed bladder cancer cases are muscle-invasive. Up to half of patients with muscle-invasive bladder cancer are not eligible to receive cisplatin and typically undergo surgery alone.
In other recent news, Merck & Co. completed its acquisition of Terns Pharmaceuticals Inc. for $5.8 billion. The transaction was finalized through a tender offer, with Merck purchasing all outstanding shares of Terns at $53.00 per share in cash. Additionally, Merck announced a $6 billion bond sale to refinance the debt incurred from the Terns acquisition. In pharmaceutical developments, Merck’s Phase 3 TroFuse-005 trial for its endometrial cancer drug, sacituzumab tirumotecan, met its primary endpoints, showing significant improvements in overall survival and progression-free survival. The trial involved 776 patients who had previously received chemotherapy and immunotherapy treatments. Furthermore, Merck entered a collaboration with Erasca Inc. to conduct a study on the combination of Merck’s KEYTRUDA and Erasca’s ERAS-0015 for treating RAS-mutant solid tumors. Merck will provide pembrolizumab at no cost for this clinical trial. Lastly, Merck published a new synthesis method for its investigational oral PCSK9 inhibitor in the journal Science, highlighting a novel biocatalytic assembly process.
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