Halaven (eribulin mesylate) has been approved by the FDA to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
The drug, marketed by Eisai Inc., is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. he microtubule inhibitor is believed to work by inhibiting cancer cell growth. Before receiving the injectable therapy, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage disease.
In a single study of 762 women with late-stage metastatic breast cancer who had received at least two prior chemotherapy regimens, patients were randomized to receive eribulin or a different single agent therapy chosen by their oncologist. The median overall survival for patients receiving eribulin was 13.1 months, compared with 10.6 months for those who received single-agent therapy.
“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” Richard Pazdur, MD, Director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release. “Halaven shows a clear survival benefit and is an important new option for women.”
The most common side effects reported were neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, weakness, peripheral neuropathy, and constipation.
Other FDA-approved therapies used to treat late-stage, refractory breast cancer include capecitabine for breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; ixabepilone for late-stage breast cancer after failure of an anthracycline, taxane, and capecitabine; and ixabepilone plus capecitabine for late-stage disease after failure of anthracycline- and taxane-based chemotherapy.
© 2010 Lippincott Williams & Wilkins, Inc.