Eisai Co. Ltd. announced that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for marketing approval of its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC).

 

An application seeking marketing approval of lenvatinib for the indication of thyroid cancer was submitted in Japan on June 26, 2014. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in Japan, Europe and the U.S. Lenvatinib was also granted an accelerated assessment in Europe by the EMA, as it is a new medicine expected to be of major public health interest, particularly from the viewpoint of therapeutic innovation.

 

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of several different RTKs including VEGFR, FGFR, PDGFRα, KIT and RET, involved in angiogenesis and tumor proliferation. This potentially makes lenvatinib a first-in-class treatment in thyroid cancer, especially given that it simultaneously inhibits the kinase activities of FGFR as well as VEGFR.

 

The applications submitted were based on a Phase 3 clinical study, known as the SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) trial, which was a multicenter, randomized, double-blind, placebo-controlled study of lenvatinib in 392 patients with RR-DTC and radiographic evidence of disease progression within the prior 13 months (patients may have received ≤1 prior VEGFR-targeted therapies). The study was conducted by Eisai in cooperation with SFJ Pharma Ltd. 

 

Compared to placebo, lenvatinib achieved a statistically significant improvement (Hazard Ratio (HR) 0.21, p<0.0001) in progression free survival (PFS), which was the primary objective of the study. The most common lenvatinib treatment-related adverse events (events with an incidence rate of at least 40%) were hypertension, diarrhea, decreased appetite, weight loss and nausea.

 

The number of patients newly diagnosed with thyroid cancer in 2012 in the U.S. and Europe was estimated to be approximately 52,000 and 53,000, respectively. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

 

Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with thyroid cancer, and their families.

 

Date: August 18, 2014

Source: Eisai