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Merck's Keytruda Combination for Bladder Cancer Recommended for Approval in Europe

Merck's Keytruda Combination for Bladder Cancer Recommended for Approval in Europe

MT newswireMT newswire2026/09/18 11:35
07:35 AM EDT, 09/18/2026 (MT Newswires) -- Merck & Co's (MRK) Keytruda in combination with Padcev as a treatment for adults with resectable muscle-invasive bladder cancer was granted a positive opinion recommending approval by the European Medicines Agency's Committee for Medicinal Products for Human Use, the company said. The company said the proposed treatment would be given before surgery and continued afterward as an additional treatment. The combination will be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein, and Norway, with a final decision expected by Q4 2026, the company said. The recommendation is based on results from a phase 3 trial showing the drug combination reduced the risk of disease progression, recurrence, or death by 47% compared with chemotherapy and surgery, the company said. The company said there was also a statistically significant improvement in overall survival, reducing the risk of death by 35%.
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