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news.Eisai has obtained Japanese marketing approval for its anticancer drug Halaven injection 1mg (eribulin mesylate) as a treatment for inoperable and recurrent breast cancer.
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Japanese approval was given on the basis a pivotal Phase III Embrace (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389) study results and a Phase II study (Study 221) results conducted in Japan.
Embrace was an open-label, randomized, multi-center, parallel two-arm study designed to compare overall survival (OS) in patients treated with Halaven versus a Treatment of Physician’s Choice (TPC).
The study results demonstrated that the patients treated with Halaven survived a median of 2.5 months longer than patients who received (TPC) (OS) of 13.1 months versus 10.6 months, respectively; Hazard Ratio [HR]).