Eisai has introduced its in-house developed new anticancer agent Lenvima (lenvatinib mesylate) in Japan to treat patients with unresectable thyroid cancer.
The company has launched the anticancer agent as Lenvima capsule 4mg and 10mg in the country.
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In Japan, Lenvima received approval with an indication for unresectable thyroid cancer that covers differentiated thyroid cancer, as well as medullary thyroid carcinoma and anaplastic thyroid carcinoma.
Discovered at the firm’s Tsukuba Research Laboratories and developed in-house, Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules such as VEGFR, FGFR, RET, KIT and PDGFR.
Specifically, the agent simultaneously inhibits VEGFR, FGFR and RET, which are involved in tumour angiogenesis and proliferation of thyroid cancer.
The SELECT study is a global Phase III trial of Lenvima that was conducted in patients with differentiated thyroid cancer. In the study, Lenvima demonstrated a statistically significant extension in progression-free survival and improved response rates compared to placebo.
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By GlobalDataIn addition, the Phase II trial (Study 208) carried out in Japan showed tolerability and efficacy of Lenvima in medullary thyroid carcinoma and anaplastic thyroid carcinoma.
The company launched Lenvima in the US in February this year. It also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2015.
The drug is currently undergoing regulatory review in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.
Eisai is also carrying out a global Phase III study of Lenvima in hepatocellular carcinoma and Phase II studies in several other tumour types, such as renal cell carcinoma and non-small cell lung cancer.
Image: Eisai has launched its Lenvima capsule 4mg and 10mg in Japan. Photo: courtesy of Eisai Co Ltd.
