Eisai Co., Ltd. announced today 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.

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.

For more details, go to: http://www.eisai.com/news/news201460.html