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news.Japan-based Eisai's UK subsidiary has received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) for anticancer agent Lenvima (lenvatinib mesylate) to treat adult patients with progressive, locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
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Lenvima is an orally administered molecular targeted agent which inhibits the activities of several different molecules such as VEGFR, FGFR, RET, KIT and PDGFR.
Mainly, the agent simultaneously inhibits VEGFR, FGFR and RET, which are especially involved in tumor angiogenesis and proliferation of thyroid cancer.
The positive opinion is based on the results of a multicenter, randomized, double-blind, placebo-controlled Phase III SELECT trial on progressive RAI refractory DTC.
Progression-free survival (PFS) is the primary endpoint of the trial, in which Lenvima showed a statistically significant extension in PFS compared to placebo.
Additionally, the trial underlines the rapid response of Lenvima, with a median time to first objective response of two months.
The in-house developed drug, which was discovered at Eisai’s Tsukuba Research Laboratories, also showed significant improvement in objective response rate compared to placebo.
In addition, Lenvima has been confirmed through X-ray co-crystal structural analysis to show a new binding mode (Type V) to VEGFR, and exhibits rapid binding to the target molecule and potent inhibition of kinase activity, according to kinetic analysis.
In February 2015, Lenvima was launched in the US to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
In Japan, Lenvima was approved in March 2015 for the treatment of unresectable thyroid cancer.
Lenvima is currently undergoing regulatory review in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.
Image: Eisai head office Tokyo, Japan. Photo: courtesy of Arthena.