18th August, 2014
EMA accepts accelerated review for orphan therapy in hard-to-treat thyroid cancer
Eisai announces today 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. This marks the beginning of the review process in the European Union for this potential new treatment.
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. This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3.,,
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) which showed that, compared to placebo, lenvatinib produced a highly statistically significant improvement in progression free survival (PFS) in patients with RR-DTC (Hazard Ratio (HR)=0.21, [95% CI, 0.14-0.31]; p<0.0001). The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively. The five most common treatment-related adverse events (TRAEs) of any grade were hypertension, diarrhoea, decreased appetite, weight loss and nausea.
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, oral lenvatinib (24mg) versus placebo. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. 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.
Thyroid cancer is the most common endocrine malignancy. In Europe alone, almost 53,000 cases of thyroid cancer were diagnosed in 2012. Although treatment is possible for most types of thyroid cancer, there remains a need for treatment options for thyroid cancer once the disease has progressed.
Lenvatinib, discovered and developed by Eisai, was filed in Japan in June 2014 and in August 2014 in the U.S. Lenvatinib was granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013. It has ODD for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer in the U.S. and thyroid cancer in Japan.
The development of lenvatinib underscores Eisai’s human health care mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of oncology and addressing the unmet medical needs of patients and their families.