Eisai's Halaven cleared for breast cancer in China

Japanese drug major Eisai (TYO: 4523) has received New Drug Approval for in-house developed anticancer agent Halaven (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA).

The approval comes two years after Eisai withdrew its new drug application for agent Halaven in China in order to submit additional documentation.

This approval is based on the results of Study 304, which was a multicenter, open-label, randomized, parallel group Phase III clinical study, to evaluate the efficacy and safety of Halaven and vinorelbine in 530 women with locally recurrent or metastatic breast cancer, previously treated with chemotherapy regimens, including an anthracycline and a taxane. Halaven demonstrated a statistically significant extension in the study’s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).