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news.Eisai's new anticancer agent Halaven (generic name: eribulin mesylate) injection has received approval from the US Food and Drug Administration (FDA) for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
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Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor and a synthetic analog of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Eisai said that the FDA approval of Halaven is based on results from the global 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 treatment of physician’s choice (overall survival of 13.12 months versus 10.65 months, respectively).
Eisai claimed that Halaven is the first and only single-agent therapy to demonstrate an overall survival benefit in patients with late-stage metastatic breast cancer.
A new drug application (NDA) for Halaven was submitted in the US in March 2010 and was granted product priority review status by the FDA.
Regulatory applications seeking approval of Eribulin mesylate as a treatment for metastatic breast cancer are also currently under review in Japan, the EU, Switzerland and Singapore.
Eisai is also planning the subsequent submission of regulatory applications in Asia and other regions in addition to the regions in which it has already filed for approval.