Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU

Wed, 03/31/2010 - 4:42am

Eisai Inc. 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.




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