Halaven Approved for Late-Stage Breast Cancer
MONDAY, Nov. 15 -- 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 constipation.
Halaven is marketed by Eisai Inc, based in Woodcliff Lakes, N.J.
The FDA has more about this approval.
Posted: November 2010