TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Mar 31, 2021 21:18 JST
Source:
Eisai
Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Renal Cell Carcinoma in Japan
TOKYO, Mar 31, 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 that Eisai has submitted an application in Japan for the additional indication of its 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 renal cell carcinoma (RCC). This is the first application to be submitted in Japan for this combination therapy.
This application is based on the results of the Phase 3 CLEAR study (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced RCC, which were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU), and simultaneously published in the New England Journal of Medicine in February 2021. In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) as well as key secondary endpoints of overall survival (OS) and objective response rate (ORR) versus sunitinib. The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported studies.
Worldwide, it is estimated that there were more than 430,000 new cases of kidney cancer diagnosed and nearly 180,000 deaths from the disease in 2020.1 In Japan, there were more than 25,000 new cases and 8,000 deaths in 2020.2 RCC is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCC.3 Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC.4,5 Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.6
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 LENVIMA and KEYTRUDA to patients with cancer.
Source: Eisai
Sectors: BioTech
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Autoinjector Named to TIME's "Best Inventions of 2025"
October 14 2025 16:54 JST
Eisai and Biogen Announce U.S. Availability of LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease
October 08 2025 11:03 JST
Eisai Highlights Breadth of Oncology Research at ESMO 2025
October 03 2025 17:01 JST
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in China
September 29 2025 09:33 JST
LEQEMBI(R) (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Australia
September 24 2025 18:04 JST
Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation
September 17 2025 17:20 JST
"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
More Press release >>
Latest Press Release
MHI Thermal Systems Air-Conditioners for the Australian Market Recognized with Prestigious Awards
Oct 17, 2025 23:37 JST
SEKISUI CHEMICAL, Fujitsu, and SAP Japan announce comprehensive modernization of management platform to drive data-driven approach
Oct 17, 2025 23:00 JST
TransNusa to Launch Bali - Singapore Scheduled Flight on November 17
Oct 17, 2025 16:58 JST
MHIEC Receives Contract for Improvement of Core Equipment at Municipal Solid Waste Incineration Facility in Kanazawa
Oct 16, 2025 23:57 JST
Overview of Honda Exhibits at Japan Mobility Show 2025
Oct 16, 2025 23:20 JST
DENSO to Exhibit at JAPAN MOBILITY SHOW 2025
Oct 16, 2025 22:53 JST
Fujitsu and IISc launch joint research on advanced AI technologies to accelerate new material development and resolve societal challenges
Oct 16, 2025 21:55 JST
Mitsubishi Motors Wins Triple Honors at Good Design Award 2025 in Japan with the Delica Mini, Destinator and Delica Series
Oct 15, 2025 21:29 JST
Mitsubishi Motors at Japan Mobility Show 2025: World Premiere of Electrified Crossover SUV Concept
Oct 15, 2025 20:35 JST
Honda to Present World Premiere of ProZision(TM) Autonomous, at Equip Exposition 2025, Honda Battery-powered Autonomous Riding Lawn Mower
Oct 15, 2025 19:56 JST
Honda to Make Additional Investment in U.S.-based Helm.ai to Further Enhance Development of Next-generation AD/ADAS
Oct 15, 2025 19:25 JST
MHI Thermal Systems Wins 2025 GOOD DESIGN AWARD for Hyper Multi LXZ Series of Building-Use Multi-Split Air-Conditioners in Japan
Oct 15, 2025 18:50 JST
Mitsubishi Power Marks 60 Years in Saudi Arabia with Unveiling of First Locally Assembled JAC Gas Turbine at Dammam Assembly Facility
Oct 14, 2025 18:21 JST
LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Autoinjector Named to TIME's "Best Inventions of 2025"
Oct 14, 2025 17:54 JST
Mazda Announces Exhibition at JAPAN MOBILITY SHOW 2025
Oct 14, 2025 17:38 JST
Hitachi Advances Strategic Alliance with Google Cloud to Empower Frontline Workers with Field-Specific AI Agents
Oct 11, 2025 00:58 JST
Honda Issues Integrated Report - "Honda Report 2025"
Oct 11, 2025 00:46 JST
DENSO's Electrification Products Adopted for TOYOTA's New "bZ4X"
Oct 11, 2025 00:21 JST
Newly developed eAxle adopted for TOYOTA's new "bZ4X"
Oct 11, 2025 00:08 JST
MHIET and MHI-TC Complete Delivery of First "COORDY" Controller Providing Optimized Control of Multiple Power Sources
Oct 10, 2025 23:47 JST
More Latest Release >>