On October 15, 2014 Eisai reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by its U.S. subsidiary Eisai Inc for its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer and granted the NDA Priority Review status (Press release Eisai, OCT 14, 2014, View Source [SID:1234500833]).

The FDA’s Priority Review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) for lenvatinib of April 14, 2015, eight months after the NDA was submitted.

Applications for marketing authorization approval of lenvatinib were submitted in Japan for the indication of thyroid cancer in June 2014 and in Europe and the U.S. for the indication of progressive, radioiodine-refractory differentiated thyroid cancer in August 2014. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in Japan, Europe and the U.S. Lenvatinib was also granted an accelerated assessment by the European regulatory authority, 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 number of patients newly diagnosed with thyroid cancer in 2012 in the U.S. was estimated to be approximately 52,000. Although treatment is possible for most types of thyroid cancer, there are very 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.