China FDA to review application for Lenvima in liver cancer

Japanese drugmaker Eisai says the China FDA has accepted its application to market Lenvima (lenvatinib) as a treatment for hepatocellular carcinoma (HCC).

The submission was based on the results of the Phase III REFLECT study comparing Lenvima with standard of care Nexavar (sorafenib), in the first-line setting.

The company says data from the study show the drug’s non-inferiority to sorafenib, as well as improvements in progression-free survival and objective response rate.

Eisai submitted applications for an additional indication for Lenvima for the treatment of HCC in Japan, Europe and the USA earlier this year.