Eisai Inc. announced today 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.
“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 FDA approval of Halaven is 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).
Overall survival was 13.12 months with Halaven versus 10.65 months with TPC (p=0.041). In an updated survival analysis, conducted when 77 percent of events had been observed, the result was consistent with the primary analysis.
The most common side effects (incidence ≥ 25 percent) reported by patients receiving Halaven were neutropenia (low white blood cells), anemia (low red blood cells), asthenia/fatigue (weakness/tiredness), alopecia (hair loss), peripheral neuropathy (numbness, tingling or burning in the hands and feet), nausea and constipation.
The most common serious side effects reported in patients receiving Halaven were neutropenia with or without fever (four percent and two percent, respectively). Severe weakness/tiredness occurred in 10 percent of patients receiving Halaven. The most common side effect resulting in discontinuation of treatment with Halaven was peripheral neuropathy (five percent).
“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.”
Source: Eisai Oncology
Eisai Inc.
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