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EMA Approves Eisai’s Lenvatinib for Accelerated Assessment in Radioiodine-Refractory Differentiated Thyroid Cancer

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July 31st, 2014

-Accelerated Review Demonstrates the Importance of Lenvatinib for This Therapeutic Area

The European Medicines Agency (EMA) has approved Eisai’s request for accelerated assessment of the investigational oral multiple receptor tyrosine kinase (RTK) inhibitor lenvatinib, for the treatment of patients with progressive radioiodine-refractory, differentiated thyroid cancer (RR-DTC). Lenvatinib is expected to be filed imminently and could become a first in a new class of tyrosine kinase inhibitors.

Thyroid cancer is the most common endocrine malignancy.[1] In Europe alone, over 50,000 cases of thyroid cancer were diagnosed in 2012.[2] Although treatment is possible for most types of thyroid cancer, there remains an unmet need for treatment options once the disease has progressed.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor 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 RTKs 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 a first-in-class treatment, especially given that it simultaneously inhibits the kinase activities of FGFR as well as VEGFR. Lenvatinib received orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer from the European Commission in April 2013.

“We are delighted that lenvatinib will undergo accelerated assessment by the EMA. The EMA recognises that RR-DTC is a challenging disease to treat and there is an urgent need for effective treatment options. At time of filing we will be another step closer to providing an innovative therapy to people with advanced thyroid cancer,” said Gary Hendler, President & CEO Eisai EMEA and President, Eisai Oncology Global Business Unit.

The EU marketing authorisation application will be based on the results of the Phase III SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) trial of lenvatinib which showed that, progression free survival (PFS) with lenvatinib was extended significantly compared to placebo (Hazard Ratio (HR)=0.21, [99% 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 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 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. Eisai hopes to receive file application in the next few months.

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 wellbeing of people worldwide. Eisai is committed to the therapeutic area of oncology and addressing the unmet medical needs of patients and their families.

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