Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Wednesday, 26 July 2017, 13:16 HKT/SGT
Share:
    

Source: Eisai
Eisai Submits Simultaneous Applications in The United States and Europe for Lenvatinib in Hepatocellular Carcinoma

TOKYO, July 26, 2017 - (JCN Newswire) - Eisai Co., Ltd. announced that it has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (HCC). This follows the application in Japan. Lenvatinib for the treatment of HCC is designated as an orphan drug by the FDA.

This application is based on the results of the REFLECT study (Study 304), a multicenter, open-label, randomized, global Phase III trial comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for HCC, as a first-line treatment for 954 patients with unresectable HCC.(1)

In the REFLECT study, lenvatinib met the primary endpoint and demonstrated an overall survival (OS) treatment effect by the statistical confirmation of non-inferiority compared to sorafenib. Developing first-line treatments for HCC is challenging, and over the past 10 years, four previous first-line Phase III studies investigating other agents compared to sorafenib have failed to achieve this endpoint in OS.(2)

Additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of Progression Free Survival (PFS), Time To Progression (TTP), and Objective Response Rate (ORR). In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.
Liver cancer is the second leading cause of cancer related death and is estimated to be responsible for 750,000 deaths per year globally (27,000 per year in the US, 62,000 per year in Europe), with 780,000 cases newly diagnosed each year (30,000 per year in the US, 63,000 per year in Europe).(3) HCC accounts for 85 percent to 90 percent of liver cancer cases. Treatment options for unresectable HCC are limited and the prognosis is very poor, making this an area of high unmet medical need.

Lenvatinib is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe, under the brand name Lenvima. Additionally, lenvatinib in combination with everolimus is approved for the treatment of renal cell carcinoma (RCC) in over 35 countries, including the United States and in Europe. In Europe, lenvatinib was launched under the brand name Kisplyx for RCC.

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.

About lenvatinib mesylate (generic name, "lenvatinib", product name: Lenvima/ Kisplyx)

Discovered and developed in-house, lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other proangiogenic and oncogenic pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRalpha; KIT; and RET) involved in tumor proliferation. Currently, Eisai has obtained approval for lenvatinib as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe, under the brand name Lenvima. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 35 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for RCC. A Phase III study of lenvatinib in separate combinations with everolimus and pembrolizumab in renal cell carcinoma (first-line) was initiated and is underway. A Phase Ib/II study to investigate the agent in combination with pembrolizumab in select solid tumors (non-small cell lung cancer, renal cell carcinoma, endometrial cancer, urothelial cancer, head and neck cancer, and melanoma) and a Phase Ib study in HCC are also underway. Following the submission of applications in Japan (June 2017), the United States and Europe (July 2017), Eisai also plans to submit an application for lenvatinib for the treatment of HCC in China within the latter half of fiscal 2017.

About the RELECT study (Study 304)(1)

The REFLECT study (A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable HCC) is a multicenter, open-label, randomized, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg (=/>60 kg) or 8 mg (<60 kg) once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity. The


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.

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120


July 26, 2017 13:16 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2017 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
Nov 6, 2017 19:37 HKT/SGT
New Data From Long-Term Extension of Phase 1B Study of Investigational Alzheimer's Disease Treatment Aducanumab Presented at 10th Clinical Trials on Alzheimer's Disease
Oct 31, 2017 12:05 HKT/SGT
Eisai's New Drug Application of Anticancer Agent Lenvatinib for Hepatocellular Carcinoma Accepted in China
Oct 31, 2017 10:27 HKT/SGT
Eisai to Present Latest Data at 10th Clinical Trials on Alzheimer's Diesase
Oct 24, 2017 10:08 HKT/SGT
Biogen and Eisai Expand Existing Collaboration Agreement to Develop and Commercialize Investigational Alzheimer's Disease Treatments Including Phase 3 Aducanumab
Oct 13, 2017 09:48 HKT/SGT
Eisai: Transfer of Rights to Anti-Rheumatic Agent Kolbet Tablets 25mg in Japan
Oct 11, 2017 11:48 HKT/SGT
Small and Easy to Take, Just One Tablet per Dose Eisai to Launch "Onji-No-Megumi" for Improving Forgetfulness in Middle Age and Beyond
Oct 4, 2017 09:49 HKT/SGT
Eisai and Biotoscana Sign Exclusive Licensing Agreement for Latin America
Oct 3, 2017 14:11 HKT/SGT
Sato Pharmaceutical and Eisai to Co-Promote New Oral Antifungal Agent Containing Active Ingredient Fosravuconazole in Japan
Sept 29, 2017 15:12 HKT/SGT
Eisai Presents Results of Phase Iii Trial of Lenvima (Lenvatinib) in Unresectable Hepatocellular Carcinoma in Oral Session at 20th CSCO Annual Meeting
Sept 27, 2017 12:25 HKT/SGT
Eisai: Application for Additional Indication of Lenvima for Hepatocellular Carcinoma Accepted for Review by U.S. FDA
More news >>
 News Alerts
Copyright © 2017 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 10 8405 3688 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6721 7212

Connect With us: