FDA Approves Eisai’s Halaven For Treating Metastatic Breast Cancer

The Food and Drug Administration Nov. 15 approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Halaven, which is marketed by Woodcliff Lakes, N.J.-based Eisai Inc., is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai, FDA said. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline-based and taxane-based chemotherapy for early or late-stage breast cancer, the agency said.

“There are limited treatment options for ...