On September 27, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") has announced that the application submitted for an additional indication of its in-house discovered and developed anticancer agent Lenvima (generic name: lenvatinib mesylate) for the treatment of hepatocellular carcinoma (HCC) has been accepted for review by the U.S. Food and Drug Administration (FDA). Lenvatinib for the treatment of HCC is designated as an orphan drug by the FDA (Press release, Eisai, SEP 27, 2017, View Source [SID1234528956]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 Lenvima versus sorafenib, a standard treatment for HCC, as a first-line treatment for patients with unresectable HCC.1
In the REFLECT study, Lenvima 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 their endpoints in OS.2
Additionally, Lenvima 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 Lenvima arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of Lenvima.
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), with 780,000 cases newly diagnosed each year (30,000 per year in the US).3 HCC accounts for 85% to 90% 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.
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 patients with cancer, their families, and healthcare providers.