Eisai said the drug has got the positive opinion as a monotherapy indicated in the treatment of patients with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens, including an anthracycline and a taxane.
CHMP’s decision was based on the positive results from a Phase III EMBRACE study, which showed an overall survival (OS) benefit for patients treated with Halaven of 2.7 months compared with TPC (13.2 months versus 10.5 months, hazard ratio 0.805, nominal p=0.014).