Halaven (eribulin mesylate) has been approved by the FDA for metastatic breast cancer treatment. Halaven is made by Eisai Inc. and can be used to treat late-stage breast cancer in patients who have already taken two previous chemo regimes. If a metastatic breast cancer patient has already been treated with an anthracycline - such as Adriamycin, and a taxane - such as Taxol, they can qualify for treatment with Halaven. This new drug is not a taxane, but is a synthetic version of halichondrin B, which occurs naturally in a marine sponge - Halichondria okadai.
Halaven passed a Phase 3 clinical trial called EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus Eribulin). The EMBRACE trial showed that metastatic breast cancer patients who took Halaven lived an average of 2.5 months longer than those who were treated with a different drug chosen by their physician. 762 patients participated in the Halaven clinical trial. "Many women with metastatic breast cancer see their disease progress after receiving multiple therapies," said Linda Vahdat, M.D., Professor of Medicine 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."
This new drug does come with a price - side effects of Halaven treatment include: neutropenia, anemia, fatigue, hair loss, peripheral neuropathy, nausea and constipation. Patients who tried Halaven but decided to stop taking this drug cited discomfort from peripheral neuropathy as their reason. Other patients complained of severe fatigue or severe neutropenia - sometimes accompanied by fever. Halaven has a small risk of causing irregular heartbeats, so heart patients who try this drug should be monitored. For patients who have liver and/or kidney problems, a lower than average dose of Halaven should be used.
Halaven in made in Japan by Eisai Inc. and will not be available in the United States until around November 25, 2010. If you qualify for Halaven treatment but need help paying for it, the company has a Patient Assistance Program you can call at 1-866-61-EISAI between 8 a.m. and 8 p.m. ET Monday through Friday.
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