Halaven Approved for Late-Stage Breast Cancer11/15/10
MONDAY, Nov. 15 (HealthDay News) -- Halaven (eribulin mesylate)
has been approved by the U.S. Food and Drug Administration to treat
metastatic (spreading) breast cancer among people who have had at
least two prior chemotherapy treatments for late-stage disease.
In a news release published Monday, the agency said breast
cancer is the second-leading cancer cause of death of among women,
citing statistics from the National Cancer Institute. Some 207,090
women are expected to be diagnosed with breast cancer this year,
resulting in 39,840 deaths, the FDA said.
Halaven, derived from a sea sponge, is believed to work by
inhibiting cancer cell growth. Its safety and effectiveness were
evaluated in clinical studies involving 762 women with metastatic
breast cancer who had had at least two prior chemotherapies for
late-stage disease. Median survival was 13.1 months among those who
took Halaven, compared to 10.6 months among those who didn't get
the drug, the agency said.
The most common adverse reactions were a decrease in white blood
cells, anemia, hair loss, fatigue, nausea, nerve damage and
Halaven is marketed by Eisai Inc, based in Woodcliff Lakes,
The FDA has more about
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