Eisai has announced that it has filed an application to the European Medicines Agency (EMA) for the use of lenvatinib in the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) accepted Eisai’s request for accelerated assessment of lenvatinib in recognition that RR-DTC is a challenging disease with an urgent need for effective treatment options.
Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor (TKI) with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors (VEGFR), in addition to other proangiogenic and oncogenic pathway-related TKIs including fibroblast growth factor receptors (FGFR), the platelet-derived growth factor (PDGF) receptor PDGFRα, KIT and RET that are involved in tumour proliferation.
The EU Marketing Authorisation Application (MAA) is based on the results of the Phase III SELECT (study of (E7080) lenvatinib in differentiated cancer of the thyroid) trial of lenvatinib (E7080). The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.
Results showed that, compared to placebo, lenvatinib produced a highly statistically significant improvement in progression free survival (PFS) in patients with RR-DTC. The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively.
The SELECT study was a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, orallenvatinib (24mg) versus placebo.
Lenvatinib, discovered and developed by Eisai, was filed in Japan in June 2014 and in August 2014 in the US. Lenvatinib was granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013.