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news.Eisai Co has reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review status to its marketing authorisation application (MAA) for Eribulin Mesylate (eribulin also known as E7389), for the treatment of inoperable or recurrent breast cancer, on May 18, 2010 .
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Eribulin is an investigational anticancer agent discovered and developed by Eisai.
Eisai filed simultaneous regulatory applications for approval of Eribulin to the health authorities in the US, Japan Switzerland, Singapore and EU, and also received priority review status by FDA on May 28, 2010.
The application submitted in Japan was 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), as well as a Phase II study (Study 221) conducted in Japan.
EMBRACE study met its primary endpoint of overall survival, demonstrating that patients who received Eribulin survived a median of 2.5 months longer than patients who received treatment of physician’s choice.
As a whole, the study demonstrated a high response rate of 23% (response observed in 17 out of 80 evaluable patients), and showed that Eribulin has a favorable tolerability profile.