New chemotherapeutic agent approved for use in late-stage breast cancer

On November 15, 2010, the US Food and Drug Administration announced the approval of Halaven (eribulin mesylate) for the treatment of patients with metastatic breast cancer who have received at least 2 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.
Halaven's safety and effectiveness were established in a single study of 762 women with metastatic breast cancer who had received at least 2 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 overall survival. The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for patients who received a single-agent therapy.

The most common adverse effects associated with the use of Halaven include neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, constipation, and peripheral neuropathy.