FDA Approves Eribulin Mesylate for the Treatment of Unresectable or Advanced Liposarcoma
First drug to show survival benefit in liposarcoma
On 28 January, 2016 the US Food and Drug Administration (FDA) approved a chemotherapy drug eribulin mesylate (Halaven) for the treatment of unresectable or advanced liposarcoma. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline.
“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
The efficacy and safety of Halaven were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or locally advanced or metastatic, and who had been treated with chemotherapy. Participants were treated with either Halaven or another chemotherapy drug - dacarbazine, until disease progression or until they were no longer able to tolerate the side effects of treatment. The study was designed to measure the overall survival. The median overall survival for patients with liposarcoma receiving Halaven was 15.6 months compared to 8.4 months for those who received dacarbazine.
The most common side effects among participants treated with Halaven were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain and pyrexia. Halaven may also cause neutropenia or decreased levels of potassium or calcium.
Serious side effects from treatment with Halaven may include neutropenia, which can increase the risk of serious infections that could lead to death, neuropathy, harm to a developing foetus, as well as QTc prolongation that may also lead to death.
The FDA granted the Halaven application priority review status, intended to facilitate and expedite the development and review of certain drugs in light of their potential to benefit patients with serious or life-threatening conditions. Halaven also received orphan drug designation, which provides incentives such as tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.
Halaven is marketed by Eisai based in Woodcliff Lake, New Jersey.