The US Food and Drug Administration (FDA) has granted approval to Halaven™ (eribulin mesylate) for the treatment of metastatic breast cancer patients who have undergone treatment with two or more prior chemotherapy regimens for advanced disease.
Metastatic breast cancer refers to cancer that has spread to distant sites in the body. Treatment of metastatic breast cancer often includes chemotherapy, but options can become limited when the cancer stops responding to conventional chemotherapy regimens.
Halaven — a synthetic form of a compound derived from the sea sponge—is a chemotherapy drug that affects cell growth.
The safety and efficacy of Halaven was evaluated in a Phase III clinical trial among 762 patients with locally recurrent or metastatic breast cancer. The women had already received an average of four prior chemotherapy drugs, including an anthracycline and a taxane. Study participants were assigned to receive either Halaven or “treatment of physician’s choice.” Because there is no single standard treatment regimen for women at this stage of breast cancer, treatment of women in the comparison group was left up to the patient’s physician.
- Median overall survival was 13.1 months among women treated with Halaven compared with 10.6 months among women treated with physician’s choice.
- The most common side effects among women treated with Halaven included low blood cell counts, hair loss, fatigue, nausea, weakness, nerve damage (peripheral neuropathy), and constipation.
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Based on these results, the FDA approved Halaven for the treatment of metastatic breast cancer in patients who have received at least two prior chemotherapy regimens for advanced disease.
 U.S. Food and Drug Administration. FDA approves new treatment option for late-stage breast cancer. November 15, 2010.
 Twelves C, Loesch D, Blum JL et al. A phase III study (EMBRACE) of eribulin mesylate versus treatment of physician’s choice in patients with locally recurrent or metastatic breast cancer previously treated with an anthracycline and a taxane. Presented at the 2010 annual meeting of the American Society of Clinical Oncology. June 4-8, 2010. Chicago, IL. Abstract CRA 1004.
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