FDA Approves New Treatment Option for Late-Stage Breast Cancer

The U.S. FDA approved Halaven to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

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 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 in 762 women with metastatic breast cancer who had received at least two