Update: Halaven (eribulin mesylate) Now FDA Approved - November 15, 2010
Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU
WOODCLIFF LAKE, N.J., March 30 /PRNewswire/ -- Eisai Inc. today announced that it has submitted simultaneous regulatory applications for approval of eribulin mesylate (also known as E7389) for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the United States and the European Union (EU). Eribulin, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai.
The submissions are based primarily on data from a pivotal, global Phase III study known as "EMBRACE" (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), which was an open-label, randomized, parallel two-arm, multi-center study of 762 women with locally recurrent or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane. The patients were treated either with eribulin (administered intravenously over two to five minutes on days 1 and 8 every 21 days) or with treatment of physician's choice. Treatment of physician's choice was defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice.
Study results showed that it met its primary endpoint of demonstrating a statistically significant improvement in overall survival in eribulin-treated patients compared with treatment of physician's choice.
The most frequent adverse events (AEs) reported by patients treated with eribulin were asthenia (fatigue), neutropenia (low white blood cell count), alopecia (hair loss), nausea and peripheral neuropathy (numbness, tingling in different parts of the body).
Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai seeks to further address the diversified needs of patients and families affected by cancer as well as healthcare professionals.
Eribulin mesylate (E7389) is an investigational agent being evaluated as a potential treatment for locally advanced or metastatic breast cancer. A non-taxane, microtubule dynamics inhibitor, it belongs to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai.
About Advanced or Metastatic Breast Cancer
Advanced or metastatic breast cancer occurs when a malignant tumor in the breast spreads from its original site to other parts of the body. Approximately 30 percent of women initially diagnosed with earlier stages eventually develop recurrent or metastatic disease. Only one in five women with metastatic breast cancer survives longer than five years.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2008 (year ended March 31, 2009) sales of approximately $3.7 billion. Eisai Inc.'s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
*On October 1, 2009, Eisai Research Institute of Boston, Inc. (established in 1987) and Eisai Medical Research Inc. (established in 2002) were merged into Eisai Inc.
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
Eisai concentrates its R&D activities in three key areas:
-- Integrative Neuroscience, including Alzheimer's disease and epilepsy. -- Integrative Oncology, including anticancer chemotherapies (small molecules and antibodies); supportive cancer therapies for nausea and vomiting. -- Vascular/Immunological Reaction, including acute coronary syndrome, atherothrombotic disease and sepsis.
Source: Eisai Inc.
CONTACT: Judee Shuler, Eisai Inc., +1-201-746-2241 (office)
Web Site: http://www.eisai.com/
Posted: March 2010
- FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma - January 28, 2016
- FDA Approves Halaven for Late-Stage Breast Cancer - November 15, 2010
- Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate - August 30, 2010
- Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application - February 1, 2008