23 4 月, 2021

Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Uterine Body Cancer in Japan

TOKYO, Apr 23, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and MSD K.K., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) announced today an application submission in Japan for the additional indication of Eisai's in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA (generic name: lenvatinib mesylate), in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s KEYTRUDA (generic name: pembrolizumab) as a treatment for patients with advanced uterine body cancer.This application is based on the results of the pivotal Phase 3 Study 309/KEYNOTE-775 for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen, which were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer in March 2021. In this trial, LENVIMA plus KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS) as well as the secondary endpoint of Objective Response Rate (ORR) versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel). The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported studies.LENVIMA plus KEYTRUDA has received orphan drug designation for a prospective indication for uterine body cancer by the Ministry of Health, Labour and Welfare, Japan (MHLW). Under this system, this application will be subject to priority review.It is estimated that there were more than 417,000 new cases of uterine body cancer diagnosed worldwide and nearly 97,000 deaths from the disease in 2020. In Japan, there were more than 17,000 new cases and more than 3,000 deaths in 2020. Endometrial carcinoma is the most common type of uterine body cancer. It is considered that more than 90% of uterine body cancers occur in the endometrium. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 17% for metastatic disease, the prognosis for these patients is poor.Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of contribution by the LENVIMA plus KEYTRUDA combination therapy to patients with cancer. For more information, visit https://www.eisai.com/news/2021/news202131.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

12 3 月, 2021

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.3The 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.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)