FDA Approves New Liposarcoma Therapy

Halaven treats liposarcoma patients who received prior chemotherapy that contained an anthracycline drug.

The FDA approved a new chemotherapy drug Thursday for the treatment of liposarcoma.

Eribulin mesylate (Halaven) is for the treatment of liposarcoma patients who received prior chemotherapy that contained an anthracycline drug and who are unable to have surgery or who have locally advanced or metastatic cancer.

“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” said Director of the Office of Hematology and Oncology Products in the FDA, Richard Pazdur, MD. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately 7 months, offering patients a clinically meaningful drug.”

Liposarcoma is a specific form of soft tissue sarcoma (STS), which are cancer cells that form in the soft tissues of the body and occurs in fat cells. Liposarcoma accounts for 18% of all soft tissue sarcomas, and although it can happen in any part of the body, it typically strikes in the head, thighs, neck, arms, and abdominal cavity.

According to the National Cancer Institute, approximately 12,000 cases of STS were diagnosed in the United States in 2014.

A clinical trial enrolled 143 patients previously treated with chemotherapy with advanced liposarcoma that is unresectable, locally advanced, or metastatic.

Patients were administered either Halaven or the chemotherapy drug dacarbazine until their side effects became intolerable or the disease spread. The median survival for patients who received Halaven was 15.6 months compared with 8.4 months on dacarbazine.

The most common side effects reported for Halaven were fatigue, nausea, constipation, hair loss, nerve damage that causes numbness in hands and feet, abdominal pain and fever, and possible low levels of white blood cells, potassium, and calcium.

Some more serious side effects that took place were a decrease in white blood cells, which can increase infections and lead to death, numbness, tingling or burning in hands and feet, harm to developing fetus, and changes in heartbeat, which could lead to death.

Halaven was previously granted priority review status and orphan drug designation by the FDA.