The Swissmedic approval was based on the results from a Phase II study (Study 211) of Halaven and the Phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice (TPC) vs Eribulin E7389).
Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of Halaven in patients with locally advanced or metastatic breast cancer who had received an anthracycline, a taxane and capecitabine as prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy.
EMBRACE was an open-label, randomized, global, multi-center, parallel two-arm study designed to compare overall survival in patients treated with Halaven versus a TPC.
Eisai‘s Halaven has already been approved in US, Singapore, the European Union and Japan.
Halaven is also currently under regulatory review in Canada.