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Pharmaceuticals / Submissions and Approvals

EMA Adopts Positive Opinion on Keytruda-Inlyta Combo

Aug. 1, 2019
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The European Medicines Agency (EMA) has granted a positive opinion for Merck’s cancer giant Keytruda (pembrolizumab) in combination with Inlyta (axitinib) for treating advanced renal cell carcinoma (RCC), the most common form of kidney cancer.

The agency’s Committee for Medicinal Products for Human Use (CHMP) made its recommendation based on findings from a pivotal Phase 3 trial, in which significant improvements were observed for overall survival, progression-free survival and objective response rate in Keytruda with axitinib compared to sunitinib.

The FDA approved the combination treatment at the end of April for the same indication. As a lung cancer drug, Merck’s Keytruda generated $2 billion in sales in Q4 2018 alone.

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