(MENAFNEditorial) First Approval Worldwide for LENVIMA for HCC
- First New Front-Line Treatment Option for HCC Approved in Japan in Nearly 10 Years
- First Approval under Global Strategic Collaboration between Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A
TOKYO, Mar, 23 2018 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), today announced that the multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate) has been approved in Japan for unresectable hepatocellular carcinoma (HCC). This is the first approval worldwide for LENVIMA for the indication of unresectable HCC and the first new systemic therapy to be approved in Japan for the front-line treatment of HCC in approximately 10 years. Additionally, this is the first regulatory approval for LENVIMA under the global strategic collaboration agreement executed in March 2018 between Eisai and Merck & Co., Inc., Kenilworth N.J., U.S.A. for the co-development and co-commercialization of LENVIMA*.
This approval was based on a Phase III clinical study (Study 304 / REFLECT study) conducted by Eisai investigating LENVIMA as a first-line treatment in patients with unresectable HCC.(1) In this study, LENVIMA demonstrated statistically significant non-inferiority of overall survival (OS) (13.6 months) compared to sorafenib (12.3 months) (hazard ratio [HR] 0.92, 95% confidence interval [CI]=0.79-1.06). Additionally, LENVIMA showed highly statistically significant and clinically meaningful improvements as compared to sorafenib in the secondary endpoints of progression free survival (PFS) (HR 0.66, 95% CI=0.57-0.77, p
About Eisai Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
MENAFN2403201800703250ID1096647098
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.