FDA Issues Approval for Halaven to Treat Patients with Liposarcoma

FDA Issues Approval for Halaven to Treat Patients with Liposarcoma
Image: Pixabay
January 28, 2016

A new treatment option for individuals suffering from a liposarcoma has been approved by the Food and Drug Administration (FDA).

The agency has issued an approval for Halaven (eribulin mesylate), a type of chemotherapy that treats both minor and advanced cancers. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

Soft tissue sarcoma (STS) is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. Liposarcoma is a specific type of STS that occurs in fat cells. In 2014, an estimated 12,000 cases of STS were diagnosed in the United States, according to the National Cancer Institute.

"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," Richard Pazdur said in a written statement. Pazdur is director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug."

The FDA granted priority review statues to Halaven. This designation is intended to encourage research and development into treatments that help patients with serious or life threatening conditions.

Additionally, the treatment was afforded orphan drug designation. This provides tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

The most common side effects among participants treated with Halaven were fatigue, nausea, hair loss, constipation, certain nerve damage causing weakness or numbness in the hands and feet, abdominal pain, and fever.

Halaven is marketed by the Eisai Company.