Industry News: Anticancer Agent Lenvatinib Designated for Priority Review and Approval by CFDA for Hepatocellular Carcinoma

03 Jan 2018


Eisai Co., Ltd. has announced that its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima / Kisplyx, lenvatinib) for use in the treatment of hepatocellular carcinoma (HCC), which was submitted for approval in China in October 2017, has been designated for Priority Review and Approval by the China Food and Drug Administration (CFDA) due to lenvatinib's significant clinical benefit compared to existing treatments. 

The Priority Review and Approval procedure was implemented by the CFDA in February 2016 with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Through designation for Priority Review and Approval, the period of time until approval is expected to be shortened. 

Liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions. Specifically, in China, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide.(1) HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary. 

Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), China (October 2017) and Taiwan (December 2017). 

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of lenvatinib as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to patients with cancer, their families, and healthcare providers.