TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
Home
Press release
Mar 23, 2021 18:34 JST
Source:
Eisai
Lenvima (Lenvatinib) Approved for Additional Indication of Unresectable Thymic Carcinoma in Japan
TOKYO, Mar 23, 2021 - (JCN Newswire) - Eisai Co., Ltd. and MSD K.K., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, has been approved in Japan for the additional indication of treatment of unresectable thymic carcinoma. This marks the first approval for LENVIMA for unresectable thymic carcinoma in Japan.
The approval was based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (REMORA study) conducted in 8 centers across Japan including the National Cancer Center Hospital, evaluating LENVIMA as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.
LENVIMA met the study's primary endpoint of objective response rate (ORR) as assessed by independent imaging review, demonstrating an ORR of 38.1% (90% confidence interval (CI): 25.6-52.0). The lower value of the CI exceeded the pre-specified statistical criteria with a threshold ORR of 10%. The most common three treatment-related adverse events were hypertension (88.1%), proteinuria (71.4%), and palmar-plantar erythrodysesthesia syndrome (69.0%), which is consistent with the safety profile observed in the previously approved indications.
Thymic carcinoma is an extremely rare disease with low prevalence. It is estimated that there are about 140 patients in Japan. For unresectable thymic carcinoma, platinum-based first-line therapy is recommended. However, since the standard treatment has not yet been established for second-line or later therapy, this is an area of high unmet medical need. In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma.
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 LENVIMA's contribution to patients with cancer.
Source: Eisai
Sectors: BioTech
Copyright ©2021 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
Biogen and Eisai Announce ADUHELM (aducanumab-avwa) Data Presentations at Alzheimer's Association International Conference 2021
July 27 2021 08:00 JST
Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma
July 23 2021 08:17 JST
Eisai to Present Latest Data on Pipeline Assets in The Area of Alzheimer's Disease and Dementia at AAIC 2021
July 21 2021 09:34 JST
Eisai Launchs Bile Acid Transporter Inhibitor Goofice in Thailand
July 19 2021 08:03 JST
Eisai Launches In-house Developed Anti-insomnia Drug Dayvigo (Lemborexant) In Hong Kong
July 01 2021 10:43 JST
Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthough Therapy Designation for Lecanemab (BAN2401)
June 24 2021 11:00 JST
Anticancer Agent "Tazverik Tablets 200mg" (Tazemetostat Hydrobromide) Approved In Japan For EZH2 Gene Mutation-positive Follicular Lymphoma
June 23 2021 14:20 JST
Eisai, Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai's MORAb-202 Antibody Drug Conjugate
June 18 2021 14:02 JST
Eisai to Divest Rights for Zonegran in Europe and Other Regions to Advanz Pharma
June 15 2021 08:00 JST
Eisai Receives Special Prize at Platinum Career Award 2021
June 09 2021 12:44 JST
More Press release >>
Latest Press Release
Biogen and Eisai Announce ADUHELM (aducanumab-avwa) Data Presentations at Alzheimer's Association International Conference 2021
Jul 27, 2021 09:00 JST
Mitsubishi Shipbuilding Holds Launch Ceremony in Shimonoseki for First MRRV for the Philippines Department of Transportation
Jul 26, 2021 15:56 JST
Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma
Jul 23, 2021 09:17 JST
Suzuki and Daihatsu Join Commercial Japan Partnership for Dissemination of CASE Technologies in Mini-commercial Vehicles
Jul 21, 2021 17:09 JST
Eisai to Present Latest Data on Pipeline Assets in The Area of Alzheimer's Disease and Dementia at AAIC 2021
Jul 21, 2021 10:34 JST
TANAKA Develops Active Brazing Filler Metal/Copper Composite Material for Power Devices
Jul 20, 2021 11:00 JST
TANAKA Develops Active Brazing Filler Metal/Copper Composite Material for Power Devices
Jul 20, 2021 11:00 JST
Woven Planet Holdings, a Subsidiary of Toyota Motor Corporation, Closes Acquisition of Lyft's Level 5 Division
Jul 20, 2021 09:01 JST
MAGICAL MONZA FOR TOYOTA GAZOO Racing
Jul 19, 2021 17:08 JST
Toyota to Launch All-New Aqua
Jul 19, 2021 13:57 JST
Record-breaker Rovanpera takes his first win driving Toyota Yaris WRC
Jul 19, 2021 10:19 JST
Eisai Launchs Bile Acid Transporter Inhibitor Goofice in Thailand
Jul 19, 2021 09:03 JST
NEC SX-Aurora TSUBASA vector supercomputer sets record in processing performance in STAC-A2 Benchmarks
Jul 16, 2021 12:34 JST
Fujitsu and France's Inria Develop New Time-Series AI Technology to Identify Causes of Data Anomalies
Jul 16, 2021 10:20 JST
Mitsubishi Motors (Thailand) Signs MoU with Eternity Grand Logistics to Do a Pilot Study on Commercial Usage of Compact EVs
Jul 16, 2021 09:26 JST
Woven Planet Holdings, a Subsidiary of Toyota, to Acquire CARMERA
Jul 15, 2021 08:07 JST
Fujitsu Transforms Nuerburgring Racetrack Safety with Artificial Intelligence
Jul 14, 2021 19:58 JST
NEC's artificial intelligence (AI) supports doctors to determine if colorectal lesions are potentially neoplastic
Jul 14, 2021 18:15 JST
Honda Reaches 15 Million-unit Mark in Cumulative Power Products Production in China
Jul 14, 2021 14:16 JST
Honda Issues "Honda Sustainability Report 2021"
Jul 14, 2021 13:11 JST
More Latest Release >>