Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Friday, 25 May 2018, 10:43 HKT/SGT
Share:
    

Source: Eisai
Eisai and Merck & Co. Provide Update on Supplemental New Drug Application (sNDA) for Lenvatinib
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.


About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our human health care philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Eisai Co., Ltd. 
Public Relations Department 
+81-(0)3-3817-5120


May 25, 2018 10:43 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2018 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
Oct 18, 2018 08:03 HKT/SGT
Eisai to Present Latest Data on Alzheimer's Disease / Dementia Pipeline at 11th Clinical Trials on Alzheimer's Disease Conference
Oct 17, 2018 08:51 HKT/SGT
Eisai and Purdue Pharma Announce Positive Topline Results of SUNRISE 2, the Second Phase 3 Pivotal Study of Lemborexant
Oct 16, 2018 17:38 HKT/SGT
Eisai Signs Collaboration Agreement for Anti-Obesity Agent Lorcaserin in Latin America With Eurofarma
Oct 12, 2018 13:48 HKT/SGT
Eisai's New Drug Application for Perampanel for Adjunctive Treatment of Partial Onset Seizures Accepted in China
Oct 10, 2018 14:35 HKT/SGT
Eisai to Present Abstracts on Oncology Products and Pipeline at ESMO 2018 Congress
Oct 5, 2018 09:30 HKT/SGT
New Data on Effect of Anti-Obesity Agent BELVIQ on Prevention and Remission of Type 2 Diabetes Presented at The European Association for the Study of Diabetes and Published in The Lancet
Oct 1, 2018 07:48 HKT/SGT
Eisai's Fycompa Newly Approved by U.S. FDA as Treatment for Partial-Onset Seizures in Pediatric Patients with Epilepsy
Sept 5, 2018 14:28 HKT/SGT
Eisai And Merck & Co. Announce China NMPA Approval of First Approval for LENVIMA (Lenvatinib) for Treatment of Unresectable HCC
Sept 3, 2018 14:50 HKT/SGT
Eisai Receives Approval for Partial Label Change for Vascular Embolization Device DC Bead
Aug 30, 2018 09:36 HKT/SGT
Eisai's LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South Korea
More news >>
 News Alerts
Copyright © 2018 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 10 8405 3688 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6721 7212

Connect With us: