The FDA has approved Eisai‘s Halaven (eribulin mesylate) Injection for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.

“Many women with metastatic breast cancer see their disease progress after receiving multiple therapies,” said Linda Vahdat, M.D., Professor of Medicine, Division of Hematology & Medical Oncology at the Iris Cantor Women’s Health Center at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City. “Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease.”

The approval of Halaven was based on results from the pivotal Phase III clinical study EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus Eribulin), which showed that patients treated with Halaven survived a median of 2.5 months longer than patients who received a single-agent therapy chosen by their physician (Treatment of Physician’s Choice).

Prior therapy should have included two common chemotherapy treatments, an anthracycline and a taxane, for early or advanced breast cancer. Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.

“The FDA approval of Halaven is significant news for the metastatic breast cancer community in an area of unmet medical need,” said Lonnel Coats, President & CEO, Eisai Inc. “This achievement is consistent with our human health care mission of striving to produce therapies that may help make a difference in the lives of patients and their families.”