primary endpoint

Pharmaceutical companies Eisai, which specializes in drugs for the treatment of neurological diseases, diseases of the gastrointestinal tract cancers, as well as in the production of drugs for intensive care and resuscitation, filed an application for registration Eribulin mesylate (netaksanovy inhibitor of microtubule dynamics) in Japan, the U.S. and the EU. The company expects to receive approval of the drug for the treatment of locally advanced or metastatic cancer of the breast.


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According to Eisai, the application is based primarily on data from the main international phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389). This was an open, randomized parallel in the two groups multicenter study involving 762 women with locally recurrent or metastatic breast cancer that have passed at least two courses of chemotherapy (anthracycline and taxanes).
During the study, patients received either intravenous Eribulin 2-5 minutes for 1 st and 8 th day every 21 days or received another treatment at the option of a doctor.



The study achieved the primary endpoint - was demonstrated statistically significant increase in overall survival in patients receiving Eribulin, compared with patients who were treated at the choice of doctor.