TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Apr 23, 2021 14:55 JST
Source:
Eisai
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) - 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
.
Source: Eisai
Sectors: BioTech
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
"New Answers to Dementia" Eisai Releases Concept Movie and New Content on Campaign Website for Dementia Month
September 12 2025 12:20 JST
Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025
September 08 2025 16:49 JST
Eisai to Present Latest Data on Lemborexant and Novel Orexin Receptor Agonist E2086 at The World Sleep 2025
September 04 2025 09:56 JST
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
September 03 2025 10:32 JST
FDA Approves LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
September 01 2025 12:44 JST
Ministry Of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anticancer Agent Tazemetostat for Unresectable INI1-Negative Epithelioid Sarcoma
August 29 2025 17:17 JST
Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI(R) (lecanemab)
August 25 2025 18:30 JST
Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO(R) (Lemborexant) in China
August 18 2025 08:11 JST
Revenue of LEQEMBI(R) (Preliminary Basis)
July 31 2025 17:27 JST
Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI(R) (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC
July 31 2025 08:30 JST
More Press release >>
Latest Press Release
The University of Osaka D3 Center Commences Operation of New Computing and Data Infrastructure Built by NEC
Sep 12, 2025 15:08 JST
GR Yaris "Aero performance package" Set for Japan Launch
Sep 12, 2025 14:40 JST
Mitsubishi Heavy Industries Achieves Target Performance at Pilot Plant for Bioethanol Membrane Dehydration Systems
Sep 12, 2025 14:19 JST
"New Answers to Dementia" Eisai Releases Concept Movie and New Content on Campaign Website for Dementia Month
Sep 12, 2025 13:20 JST
TANAKA PRECIOUS METAL TECHNOLOGIES Succeeds in Developing High-Performance Palladium Alloy Hydrogen Permeable Membrane Operable in the Low-Temperature Range of 300 degrees C
Sep 12, 2025 11:00 JST
CO2NNEX(R) Digital Platform for Transfer and Management of e-Methane Clean Gas Certificates to Be Utilized in Nagaoka Methanation Demonstration
Sep 11, 2025 20:37 JST
Hitachi accelerates growth with major U.S. investments in advanced manufacturing, electrification and workforce development
Sep 11, 2025 18:35 JST
GlobalLogic and Ericsson Deploy Private 5G Network at Hitachi Rail's State-of the-Art Digital Factory
Sep 11, 2025 17:24 JST
GlobalLogic and Flexware Innovation Announce Major Deployment of LIFT at Hitachi Rail's State-of-the-Art Train Manufacturing Facility
Sep 11, 2025 16:46 JST
JCB Unveils New Brand Message in Vietnam: "Japan Cung Ban"
Sep 11, 2025 13:00 JST
Kawasaki City becomes first dekokatsu subsidy municipality for promoting decarbonization lifestyle promotion project
Sep 11, 2025 10:35 JST
TGR Plans to Reproduce Engine Parts for Corolla Levin / Sprinter Trueno (AE86)
Sep 10, 2025 18:11 JST
TANAKA Acts as Category Sponsor for the LIGA.i Blind Soccer Top League 2025
Sep 10, 2025 03:00 JST
Toyota Submits Fourth Progress Report on Measures to Prevent Recurrence
Sep 09, 2025 19:26 JST
The 46th Honda Prize 2025 Awarded to Dr. Kenichi IGA
Sep 09, 2025 19:06 JST
Lexus world premieres the new IS
Sep 09, 2025 18:26 JST
Toni Bou Wins 19th Consecutive FIM Trial World Championship Title
Sep 08, 2025 18:53 JST
Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025
Sep 08, 2025 17:49 JST
Honda to Commercialize UNI-ONE Hands-Free Personal Mobility Device
Sep 08, 2025 15:56 JST
Mitsubishi Power Signs Contract to Supply Two M701JAC Gas Turbines to O Mon 4 Power Plant
Sep 08, 2025 15:36 JST
More Latest Release >>