|
| Friday, 25 May 2018, 10:43 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
|
| In First-line Unresectable Hepatocellular Carcinoma |
TOKYO, May 25, 2018 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for the multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate) for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
The FDA has indicated that the extension of the Prescription Drug User Fee Act (PDUFA) date is needed to allow additional time for review of the application. The agency expects to complete the review on or before August 24, 2018, thus extending the target action date by a standard extension period of three months from the original PDUFA action date of May 24, 2018.
Eisai, as the marketing authorization holder, is working closely with the FDA to support the continued review of this application.
LENVIMA is approved by the U.S. FDA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). LENVIMA is also approved by the U.S. FDA in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.
About LENVIMA (lenvatinib mesylate)
Discovered by Eisai, LENVIMA is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRalpha; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.
Currently, LENVIMA is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 40 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma.
LENVIMA is approved as a monotherapy for unresectable hepatocellular carcinoma in Japan (March 2018).
Eisai has submitted applications for an indication covering hepatocellular carcinoma in the United States and Europe (July 2017), China (October 2017), Taiwan (December 2017) and other countries.
About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
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. Under the agreement, the companies will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck & Co., Inc. Kenilworth N.J., U.S.A.'s anti-PD-1 therapy. In addition to ongoing clinical studies of the combination, the companies will jointly initiate new clinical studies evaluating the combination to support 11 potential indications in six types of cancer, as well as a basket trial targeting six additional cancer types. The combination is not approved in any cancer types today.
Contact:
Eisai Co., Ltd.
Public Relations Department
+81-(0)3-3817-5120
Topic: Press release summary
Source: Eisai
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Dec 23, 2024 16:22 HKT/SGT |
|
Fujirebio and Eisai Enter into Memorandum of Understanding for Joint Research and Social Implementation of Blood-based Biomarkers in the Field of Neurodegenerative Diseases |
| Dec 11, 2024 13:45 HKT/SGT |
|
Eisai's "URECE(R)" (Dotinurad) Approved in China for Gout Patients with Hyperuricemia |
| Dec 5, 2024 10:22 HKT/SGT |
|
"LEQEMBI" (Lecanemab) Approved for the Treatment of Early Alzheimer's Disease in Mexico |
| Nov 28, 2024 15:26 HKT/SGT |
|
LEQEMBI (Lecanemab) for the Treatment of Alzheimer's Disease Launched in South Korea |
| Nov 26, 2024 14:50 HKT/SGT |
|
Eisai Signs Research Collaboration Agreement with The National Center of Neurology and Psychiatry to Initiate Apolipoprotein E Genetic Testing in the "AD-DMT Registry" in Japan |
| Nov 20, 2024 10:51 HKT/SGT |
|
Rozebalamin for Injection 25mg (Mecobalamin) for Amyotrophic Lateral Sclerosis Launched in Japan |
| Nov 20, 2024 09:24 HKT/SGT |
|
Anticancer Agent "TASFYGO Tablets 35mg" (Tasurgratinib Succinate) Launches in Japan for Biliary Tract Cancer with FGFR2 Gene Fusion or Rearrangements |
| Nov 15, 2024 16:33 HKT/SGT |
|
Nationwide TV Commercial Launched in Japan to Raise Awareness About MCI (Mild Cognitive Impairment) |
| Nov 15, 2024 13:31 HKT/SGT |
|
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease |
| Nov 5, 2024 10:35 HKT/SGT |
|
Eisai's Corporate Venture Capital Subsidiary, Eisai Innovation, Inc., Selected for AMED's 'Strengthening Program for Pharmaceutical Startup Ecosystem" |
| More news >> |
 |
|
|
|
