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8 Feb 2016

FDA Approves Eisai’s Halaven® (eribulin mesylate) Injection for the Treatment of Patients with Advanced Liposarcoma

U.S. Food and Drug Administration (FDA) approved Halaven® (eribulin mesylate) Injection (0.5 mg per mL) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

This marks the second indication for which Halaven has been approved by the FDA based on a statistically significant extension of survival.

Halaven was first approved in the United States on November 15, 2010, for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Previous therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Halaven is the first and only single agent to significantly extend overall survival in the third-line for patients with metastatic breast cancer.

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