FDA Oks New Use for Eisai Cancer Drug

The US Food and Drug Administration (FDA) has approved Eisai’s anticancer agent, Halaven (eribulin mesylate) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Following approval for use in the treatment of metastatic breast cancer in the United States, this marks the second indication for which Halaven has been approved by the FDA.

Applications seeking approval of Halaven for use in the treatment of soft tissue sarcoma have been submitted in Europe and Japan. Meanwhile, the agent has been designated as an orphan drug for the treatment of soft tissue sarcoma in the United States and Japan.

Halaven is a halichondrin class microtubule dynamics inhibitor. It was first approved in the United States in November 2010 for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Halaven is currently approved for use in the treatment of breast cancer in approximately 60 countries, including Japan and countries in Europe, the Americas, and Asia.

Source: Eisai

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