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Merck: FDA grants breakthrough therapy designation

(CercleFinance.com) - The US Food and Drug Administration has granted breakthrough therapy designation for Merck's immunotherapy Keytruda, in combination with Eisai's Lenvima, for the treatment of patients with advanced unresectable hepatocellular carcinoma, the US drugmaker said on Tuesday.


While the Keytruda plus Lenvima combination is investigational and not approved in any cancer types today, this is the third breakthrough therapy designation for the combo.

Hepatocellular carcinoma - or liver cancer - is often diagnosed at an advanced stage and has one of the highest mortality rates of solid cancers, with a five-year survival rate of about 18%.

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