Eisai's Halaven gets FDA approval for soft tissue sarcoma

Japanese drug major Eisai (TYO: 4523)  on Friday said the US Food and Drug Administration has approved its anticancer agent Halaven (eribulin mesylate) to treat liposarcoma, a specific type of soft tissue sarcoma.

Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said, “Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time. The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”

Halaven is a type of chemotherapy and will be used to treat liposarcoma that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.