FDA Approves Eisai's Halaven to Treat Liposarcoma
January 28 2016 - 4:00PM
Dow Jones News
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 maria.armental@wsj.com
(END) Dow Jones Newswires
January 28, 2016 16:45 ET (21:45 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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