FDA Approves Eribulin Mesylate for Advanced Liposarcoma
February 11, 2016, by NCI Staff
The Food and Drug Administration (FDA) approved eribulin mesylate (Halaven®) on January 28 for some patients with liposarcoma. The approval is for patients whose cancers are advanced (metastatic) or cannot be removed by surgery (unresectable) and are no longer responding to anthracycline-based chemotherapy.
“The approval offers a therapeutic option for a disease with minimal treatment options,” said Chris Heery, M.D., director of the Clinical Trials Group in NCI’s Center for Cancer Research.
The drug’s approval was based on the findings in a subgroup of 143 patients with advanced liposarcoma who were participating in a randomized phase III clinical trial of eribulin mesylate. Patients in the trial (which also included patients with another type of sarcoma, leiomyosarcoma) were randomly assigned to receive eribulin mesylate or the chemotherapy drug dacarbazine until their disease progressed or until they were no longer able to tolerate the side effects of treatment.
The median overall survival for patients with liposarcoma treated with eribulin mesylate was 15.6 months, compared with 8.4 months for those who received dacarbazine.
In the trial, treatment-related side effects were more common in patients who received eribulin mesylate, including neutropenia and peripheral neuropathy. High-grade side effects were also more frequent, but manageable, in the eribulin-treated patients.
“The approval of an agent that improves overall survival offers a backbone of therapy for the future upon which we can hope for greater improvements in this difficult-to-treat disease,” said Dr. Heery.
In October 2015, the FDA approved another drug, trabectedin (Yondelis®), for patients with advanced liposarcoma and leiomyosarcoma. It’s not clear yet “what the best order of these agents will be for liposarcoma,” Dr. Heery said, “but it is exciting to have two treatment options for patients with this difficult disease.”