FDA Approves New Drug for Late-Stage Breast Cancer
December 13, 2010
Women with late-stage breast cancer who have already received chemotherapy at least twice for their condition have a new ally: Halaven™ (eribulin mesylate) has now been approved by the U.S. Food and Drug Administration (FDA) for these patients.
Halaven, an injectable drug based on a compound found in a sea sponge, is a microtubule inhibitor that works by hampering the growth of cancer cells. The drug is manufactured by Eisai, Inc.
The safety and effectiveness of Halaven were substantiated in a clinical trial involving 762 women with metastatic breast cancer who had already been treated with anthracycline- and taxane-based chemotherapy. Women who received Halaven had a longer overall average survival rate than women who received a different therapy from their oncologist.
"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said FDA official Richard Pazdur, M.D. "Halaven shows a clear survival benefit and is an important new option for women."
The most common side effects reported with Halaven are leukopenia (a decrease in white blood cells), anemia, hair loss, fatigue, nausea, weakness, nerve damage and constipation.
Source: FDA news release
