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FDA approves Halaven for metastatic, unresectable liposarcoma
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The FDA today approved the chemotherapy drug eribulin mesylate for the treatment of patients with unresectable or metastatic liposarcoma who previously received anthracycline-containing chemotherapy.
Liposarcoma is a type of soft tissue sarcoma that occurs in fat cells, appearing most commonly in the head, neck, arms, legs, trunk and abdomen. Twelve thousand patients were diagnosed with liposarcoma in the U.S. in 2014, according to data from the NCI.
Richard Pazdur, MD,
The FDA based its decision in part on results of a trial composed of 143 patients with unresectable, locally advanced or metastatic liposarcoma who previously received chemotherapy. Patients received eribulin mesylate (Halaven, Eisai) or dacarbazine until disease progression or the occurrence of intolerable adverse events.
OS served as the study’s primary outcome.
Median OS among patients assigned eribulin mesylate was 15.6 months, whereas patients assigned dacarbazine achieved an 8.4-month median OS.
“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
Patients treated with eribulin mesylate frequently experienced fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain and pyrexia. Serious adverse events also may include decreased white blood cell count, neuropathy and QTc prolongation that may lead to death.
Eribulin mesylate previously received priority review and orphan drug designation for this indication.