Eisai Inc. Received U.S Food and Drug Administration for Eisai’s Halaven Injection

Eisai Inc. announced that the United States Food and Drug Administration (FDA) has approved 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.

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.

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 said, Many women with metastatic breast cancer see their disease progress after receiving multiple therapies. Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease.