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Eisai seeks Taiwanese expanded indication approval for anticancer agent Lenvima to treat hepatocellular carcinoma

Tokyo
Thursday, December 7, 2017, 11:00 Hrs  [IST]

Eisai Co has submitted an application for its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima/Kisplyx, product name in Taiwan: "Lenvima") for an additional indication for use in the treatment of hepatocellular carcinoma (HCC) in Taiwan. This application for the HCC indication for Lenvima follows the submission of respective applications in Japan and China in Asia.

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 Taiwan, there are approximately 10,000 new cases and 8,000 deaths per year. HCC accounts for 85% to 90% of primary liver cancer cases. Treatment options for unresectable HCC are limited. Therefore, HCC is extremely difficult to treat, and the development of new treatments is necessary.

Eisai submitted applications for an additional indication for Lenvima for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), and China (October 2017). In Taiwan, Eisai obtained approval for Lenvima as a treatment for patients with radioactive iodine-refractory differentiated thyroid cancer in September 2016 and in combination with everolimus as a treatment for renal cell carcinoma (second-line) in July 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 Lenvima as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to cancer patients, their families, and healthcare providers worldwide.

 

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