FDA approves first drug to show survival benefit in liposarcoma

FDA approved on Thursday eribulin mesylate (Halaven—Eisai) for the treatment of unresectable or advanced liposarcoma. The treatment is approved for patients who previously had undergone chemotherapy with an anthracycline drug.

FDA approved on Thursday eribulin mesylate (Halaven—Eisai) for the treatment of unresectable or advanced liposarcoma. The treatment is approved for patients who previously had undergone chemotherapy with an anthracycline drug. Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, noted that eribulin mesylate "is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time. The clinical trial data the FDA reviewed indicates that [eribulin mesylate] increased overall survival by approximately 7 months, offering patients a clinically meaningful drug." Adverse events associated with the drug include fatigue, nausea, alopecia, constipation, peripheral neuropathy, and pyrexia. Serious adverse events that may result from treatment with eribulin mesylate include a decrease in white blood cell count, neuropathy, harm to a developing fetus, and changes in heartbeat that may also lead to death.