Halaven Approved for Liposarcoma
The United States Food and Drug Administration (FDA) has approved the chemotherapy agent Halaven (eribulin) for the treatment of liposarcoma. It’s the first drug approved for liposarcoma that has demonstrated an improvement in overall survival. Halaven is already approved for the treatment of advanced breast cancer.
The approval indication for Halaven in the treatment of liposarcoma specifies that patients must have either advanced cancer and/or cancer that’s not able to be surgically removed. Patients must also have received prior therapy with chemotherapy from the class of agents referred to as anthracyclines.
Liposarcoma is a type of cancer referred to as a soft-tissue sarcoma (STS). Soft-tissue sarcomas can start in cells that comprise soft tissues in the body, including muscles, tendons, fat, blood vessels, lymph vessels, nerves, and tissues that surround joints. Liposarcoma is a type of STS that starts in cells of the fat.
According to the National Cancer Institute, approximately 12,000 patients were diagnosed with liposarcoma in the U.S. in 2014.
The trial prompting the approval of Halaven for liposarcoma (Halaven is already approved for advanced breast cancer), included 143 patients with advanced liposarcoma who had already been treated with chemotherapy. Patients in the trial were treated with either Halaven or dacarbazine until their cancer started progressing, or until they were no longer able to tolerate side effects of therapy.
- Overall survival time was 15.6 months for patients treated with Halaven, compared to only 8.4 months for patients treated with dacarbazine.
- The most common side effects associated with Halaven were fatigue, nausea, hair loss, constipation, and weakness/numbness in the hands and feet.
According to the FDA press release announcing the new approval, Richard Pazdur, M.D, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, stated that “Halaven 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 Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
Reference: United States Food and Drug Administration. FDA approves first drug to show survival benefit in liposarcoma. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483714.htm. Accessed January 28, 2016.
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