FDA Approves Halaven for Late-Stage Breast Cancer

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

Halaven is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. This injectable therapy is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai.

According to the National Cancer Institute, breast cancer is the second leading cause of cancer related death among women. This year, an estimated 207,090 women will be diagnosed with breast cancer and 39,840 women will die from the disease.

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.

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The study was designed to measure overall survival, defined as the length of time from when this treatment started until a patient's death. The median overall survival for patients receiving Halaven was 2.5 months longer, 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.

“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."

Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

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.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

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