Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anti-Cancer Agent Lenvima (Lenvatinib) With Prospective Indication for Uterine Body Cancer
TOKYO, Mar 12, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that it has received orphan drug designation for LENVIMA (generic name: lenvatinib mesylate), the orally available multiple receptor kinase inhibitor discovered by Eisai, with a prospective indication for uterine body cancer, by the Ministry of Health, Labour and Welfare (MHLW).
In Japan, the estimated number of patients with uterine body cancer is approximately 30,000.1 It is estimated that in 2020, there were more than 17,000 new cases of uterine body cancer and more than 3,000 deaths from the disease.2 It is considered that more than 90% of uterine body cancers occur in the endometrium.3
The pivotal Phase 3 Study 309/KEYNOTE-775 evaluated LENVIMA in combination with KEYTRUDA (generic name: pembrolizumab) in patients with advanced endometrial cancer (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen in Japan, the United States, Europe and other countries. In this study, LENVIMA plus KEYTRUDA met its dual primary endpoints, overall survival (OS) and progression-free survival (PFS), as well as its secondary efficacy endpoint of objective response rate (ORR). Currently, Eisai is preparing to submit an application for additional indications based on these results in various countries around the world including Japan.
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA.
Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of LENVIMA for cancer treatment, as it seeks to contribute addressing the diverse needs of, and increasing the benefits provided to, patients with cancer and their families.
Public Relations Department,
Eisai Co., Ltd.
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