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news.Japanese pharmaceutical firm Eisai's US subsidiary has launched its in-house developed new anticancer agent Lenvima (lenvatinib mesylate) in the country to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
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Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of an array of different molecules including VEGFR, FGFR, RET, KIT and PDGFR. VEGFR, FGFR and RET are especially involved in tumor angiogenesis and proliferation of thyroid cancer.
In addition, the agent has been confirmed through X-ray crystal structural analysis to show a new binding mode (Type V) to VEGFR2, and exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis.
In a multicenter, randomized, double-blind, placebo-controlled Phase III placebo controlled SELECT trial, Lenvima showed a statistically significant improvement in progression-free survival compared to placebo as well as response rate.
A total of 392 patients were included in the trial, which compared the progression-free survival (PFS) of patients with radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral Lenvima (24mg) versus placebo.
The results from the Phase III trial also demonstrated that patients treated with Lenvima lived a median of 18.3 months without their disease progressing, compared to a median of 3.6 months for participants who received a placebo.
Earlier in February 2015, the company secured approval from the US Food and Drug Administration (FDA) for Lenvima, based on the agency’s priority review system.
Lenvima is currently undergoing regulatory review in Japan, the European Union (EU), as well as in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.