Merck: CHMP gives green light for Keytruda in pleural mesothelioma
(CercleFinance.com) - Merck announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for the approval of Keytruda (pembrolizumab), in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adults with unresectable malignant non-epithelioid pleural mesothelioma.
This recommendation is based on the results of a pivotal study (IND.227/KEYNOTE-483), which showed 'a significant improvement in overall survival compared with chemotherapy alone'.
The European Commission's final decision is expected in the fourth quarter of 2024.
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