Drug Information Update - FDA approves first drug to show survival benefit in liposarcoma

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The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). 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. STS can form almost anywhere in the body, but is most common in the head, neck, arms, legs, trunk and abdomen. In 2014, an estimated 12,000 cases of STS were diagnosed in the United States, according to the National Cancer Institute.

The most common side effects among participants treated with Halaven were fatigue, nausea, hair loss (alopecia), constipation, certain nerve damage causing weakness or numbness in the hands and feet (peripheral neuropathy), abdominal pain and fever (pyrexia). Halaven may also cause low levels of infection-fighting white blood cells (neutropenia) or decreased levels of potassium or calcium.

Serious side effects from treatment with Halaven may include a decrease in white blood cell count, which can increase the risk of serious infections that could lead to death; numbness, tingling or burning in the hands and feet (neuropathy); harm to a developing fetus; as well as changes in heartbeat (QTc prolongation), that may also lead to death.

For more information, please visit: Halaven