EC approves anticancer agent Lenvima for treatment of advanced thyroid cancer
Posted: 1 June 2015 |
The EC has approved Lenvima in the treatment of adult patients with progressive, locally advanced or metastatic differentiated thyroid carcinoma…
Eisai has received approval from the European Commission (EC) for anticancer agent Lenvima® (lenvatinib mesylate) in the treatment of adult patients with progressive, locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Lenvima was granted an accelerated assessment by the European Medicines Agency, and was ultimately approved in approximately 9 months since the application was filed on August 14, 2014.
The decision by the EC was based on the results of a multicentre, randomised, double-blind, placebo-controlled Phase III study (the SELECT study) on progressive RAI refractory DTC1 . In the study’s primary endpoint of progression-free survival (PFS), Lenvima demonstrated a statistically significant extension in PFS compared to placebo.
Lenvima demonstrated a rapid response in the SELECT study
In addition, the study underlines the rapid response of Lenvima, with a median time to first objective response of 2.0 months. Furthermore, Lenvima demonstrated a statistically significant improvement in objective response rate. In particular, complete response was observed in 1.5% (4 patients) of the Lenvima group and none in the placebo group.
Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR. In particular, the agent simultaneously inhibits VEGFR, FGFR and RET, which are especially involved in tumour angiogenesis and proliferation of thyroid cancer. Furthermore, Lenvima has been confirmed through X-ray co-crystal structural analysis to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits potent inhibition of kinase activity and rapid binding to the target molecule according to kinetic analysis.
Thyroid cancer affects more than 52,000 people in Europe each year. 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 Lenvima in order to further contribute to patients with cancer and their families.