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Merck, Eisai Receive Positive CHMP Opinions For Keytruda + Lenvima In Two Different Types Of Cancer

Merck & Co. Inc. (MRK) and Eisai said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted positive opinions recommending approval of the combination of Keytruda, Merck's anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for two different indications.

One positive opinion is for the first-line treatment of adult patients with advanced renal cell carcinoma, and the other is for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

Decisions on the CHMP's recommendations will be given by the European Commission for marketing authorization in the EU, and are expected in the fourth quarter of 2021.

LENVIMAis marketed as KISPLYX in the European Union for the treatment of advanced renal cell carcinoma or RCC.

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