FDA Approves Eribulin Mesylate (Halaven) for Liposarcoma

Treatment extends survival compared with dacarbazine

The FDA has approved eribulin mesylate (Halaven, Eisai), a form of chemotherapy, for the treatment of unresectable or metastatic liposarcoma, a type of soft-tissue sarcoma (STS). The treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

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 U.S., according to the National Cancer Institute.

The efficacy and safety of eribulin mesylate were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes (locally advanced) or other parts of the body (metastatic), and who had been treated with chemotherapy. Participants were treated with eribulin or another chemotherapy drug, dacarbazine, until their disease spread or until they were no longer able to tolerate the adverse effects of treatment. The study was designed to measure overall survival (the length of time from the start of treatment until a patient’s death). The median overall survival for patients with liposarcoma receiving eribulin mesylate was 15.6 months compared with 8.4 months for those who received dacarbazine.

The most common adverse events among participants treated with eribulin included fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and fever. Eribulin may also cause neutropenia or decreased levels of potassium or calcium.

Serious adverse events resulting from treatment with eribulin mesylate may include a decrease in the white blood cell count, which can increase the risk of serious infections that could lead to death; neuropathy; harm to a developing fetus; and QTc prolongation, which may also lead to death.

The FDA granted priority review status to the eribulin mesylate application. Eribulin also received an orphan drug designation, which is meant to encourage the development of treatments for rare diseases.

Source: FDA; January 28, 2016.