Eisai announces phase III data for Halaven
10 July 2012 11:55 in Pharmaceutical Company Product News
Eisai has revealed the preliminary results from a phase III study of its anti-cancer agent Halaven (eribulin mesylate) versus capecitabine in female breast cancer sufferers.
Involving patients for whom prior treatment with both anthracycline and taxane has failed, the study was a randomised trial involving 1,102 women with locally advanced or metastatic breast cancer.
The results showed the trial did not meet pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS), although there was a trend toward improved OS for patients who received Halaven compared with capecitabine.
In addition, the safety profile of Halaven was consistent with the findings of previous clinical trials.
Eisai said it will "work closely with the health authorities towards potential regulatory filing" for Halaven, which is already approved for the treatment of breast cancer in 37 countries.
The drug is a synthetic analogue of halichondrin B, a substance identified in a marine sponge that lives off the coast of Japan.
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