The Food and Drug Administration (FDA) has approved Halaven (eribulin mesylate) to
treat patients with metastatic breast cancer who have received at least two
prior chemotherapy regimens for late-stage disease.
Halaven is a synthetic form of a chemotherapeutically active
compound derived from the sea sponge Halichondria okadai. This injectable
therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell
growth. Before receiving Halaven, patients should have received prior
anthracycline- and taxane-based chemotherapy for early or late-stage breast
cancer.
Safe and effective
Halaven's safety and effectiveness were established in a
single study in 762 women with metastatic breast cancer who had received at
least two prior chemotherapy regimens for late-stage disease. Patients were
randomly assigned to receive treatment with either Halaven or a different
single agent therapy chosen by their oncologist.
The study was designed to measure the length of time from
when this treatment started until a patient's death (overall survival). The
median overall survival for patients receiving Halaven was 13.1 months compared
with 10.6 months for those who received a single agent therapy.
The most common side effects reported by women treated with
Halaven include a decrease in infection-fighting white blood cells
(neutropenia), anemia, a decrease in the number of white blood cells
(leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve
damage (peripheral neuropathy), and constipation.
Other options
"There are limited treatment options for women with
aggressive forms of late-stage breast cancer who have already received other
therapies," said Richard Pazdur, M.D., director of the Office of Oncology Drug
Products in the FDA's Center for Drug Evaluation and Research. "Halaven
shows a clear survival benefit and is an important new option for women."
Other FDA-approved therapies used to treat late-stage,
refractory breast cancer include Xeloda (capecitabine) for patients with breast
cancer resistant to paclitaxel and anthracycline-containing chemotherapy;
Ixempra (ixabepilone) for patients with late-stage disease after failure of an
anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with
late-stage disease after failure of anthracycline- and taxane-based
chemotherapy.
Breast cancer is the second leading cause of cancer related
death among women, according to the National Cancer Institute. This year, an estimated
207,090 women will be diagnosed with breast cancer, while 39,840 women will die
from the disease.
Halaven is marketed by Woodcliff Lakes, N.J.-based Eisai Inc.
