SILVER SPRING, Md. — The Food and Drug Administration announced Thursday that it had approved the first chemotherapy drug that has show improved survival time in patients with unresectable or metastatic liposarcoma.
Halaven (eribulin mesylate), marketing by Eisai, showed in clinical trials that it could increase overall survival by about seven months, according to Dr. Richard Pazdur, director of the FDA’s Center for Drug Evaluation and Research Office of Hematology and Oncology Products.
Halaven was given priority review status by the FDA, and received orphan drug designation. It is approved for patients with unresectable or metastatic liposarcoma who have received prior chemotherapy that contained an anthracycline drug.