Eisai introduces in-house developed thyroid cancer drug Lenvima in Japan

In Japan, Lenvima is the first molecular targeted treatment approved with an indication for unresectable thyroid cancer which covers differentiated thyroid cancer as well as medullary thyroid carcinoma and anaplastic thyroid carcinoma.

In a global Phase III study (SELECT) conducted in patients with differentiated thyroid cancer, Lenvima showed a statistically significant extension in progression free survival (PFS) and improved response rates compared to placebo.

The most common Lenvima treatment-related adverse events observed in this trial were hypertension, diarrhea, fatigue or asthenia, decreased appetite and weight loss.

In addition, a Phase II trial (Study 208) conducted in Japan showed tolerability and efficacy of Lenvima in medullary thyroid carcinoma and anaplastic thyroid carcinoma as well.

In Japan, the number of patients with thyroid cancer is expected to be between 13,000 and 29,000.

The company expects that Lenvima will make a contribution to patients as a new standard treatment for unresectable thyroid cancer, which currently has no established standard treatment in Japan.

Lenvima, which is discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR.

In the US, Lenvima was launched in February this year, and received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use in March 2015.

Currently, Lenvima is undergoing regulatory review in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.

Image: Lenvima capsule 4mg, Lenvima capsule 10mg. Photo: courtesy of Eisai Co., Ltd.