USFDA approve Eisai’s anticancer agent

Eisai announced today that its US subsidiary Eisai Inc. has received USFDA approval for its in-house developed novel anticancer agent Lenvima (lenvatinib mesylate).


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It is said to serve as a treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).

Lenvima was granted priority review status by the FDA, and was ultimately approved six months from the submission of the New Drug Application in August 2014, two months ahead of the FDA priority review action date.

This marks the first country in the world where the agent has received marketing authorization.

Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR.

In particular, the agent simultaneously inhibits VEGFR, FGFR and also RET which are especially involved in tumor angiogenesis and proliferation of thyroid cancer.

Furthermore, Lenvima has been confirmed through X-ray crystal structural analysis to be the first compound to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis.

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