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Thursday, August 16, 2018

Merck, Eisai announce FDA approval of liver cancer med


Eisai Inc. (ESALY) and Merck (MRK) announced that the U.S. FDA approved the kinase inhibitor LENVIMA for the first-line treatment of patients with unresectable hepatocellular carcinoma. This approval was based on results from REFLECT, where LENVIMA demonstrated a proven treatment effect on overall survival by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.

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