FDA Approves Eisai's Halaven to Treat Liposarcoma

U.S. health regulators on Thursday approved Eisai Co.'s cancer drug Halaven to treat liposarcoma, a rare cancer of the connective tissues.

The U.S. Food and Drug Administration approved Halaven, or eribulin mesylate, to treat cancer patients who had received chemotherapy that contained an anthracycline drug, anti-tumor antibiotics that interfere with the enzymes involved in DNA replication.

Clinical trial data indicated Halaven increased overall survival by about seven months.

Liposarcoma is a type of soft-tissue sarcoma that occurs in fat cells. It is most common in the head, neck, arms, legs, trunk and abdomen.

Serious side effects from Halaven treatment, the FDA said, could include a lower white blood cell count, which can increase the risk of serious infections and changes in heartbeat.

Halaven derives from halichondrin B, a substance identified in a black sponge that lives off the coast of Japan. Studies showed it has a powerful effect on tumors, blocking cell division in a way that scientists hadn't previously thought of.

Eisai, a Japanese pharmaceutical company that had made billions of dollars on a treatment for Alzheimer's disease before it lost patent protection, launched Halaven in the U.S. in 2010 as a treatment for late-stage breast cancer.

For the year ended March 31, Halaven accounted for about 6% of Eisai's annual revenue.

Peter Landers contributed to this article.

Write to Maria Armental at [e-mail]

(END) Dow Jones Newswires

January 28, 2016 16:45 ET (21:45 GMT)

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