FDA approves breast cancer drug Halaven for liposarcoma28 Jan 2016
The microtubule inhibitor eribulin mesylate (Halaven), previously approved for breast cancer, now also has an indication as second-line therapy for liposarcoma, the FDA announced.
"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement. "The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately 7 months, offering patients a clinically meaningful drug."
Clinical findings with “"landmark significance" for the patients
In announcing the approval, the FDA cited a randomized trial comparing eribulin to a standard chemotherapy drug; median overall survival with eribulin was 15.6 months versus with 8.4 months with dacarbazine.
Those results came from a phase 3 trial reported last year, which tested the drug in a mix of soft-tissue sarcomas. About a third of the patients in that study had liposarcoma. Eribulin seemed to be especially effective in that population. The finding of an overall survival improvement was seen as having "landmark significance."
The FDA's approval of eribulin in liposarcoma specifies that it's for patients who previously received chemotherapy, including an anthracycline agent.
What about the adverse events?
Adverse effects are similar to those seen with other anti-cancer drugs, including fatigue, gastrointestinal symptoms, alopecia, peripheral neuropathy, neutropenia, and low electrolyte levels. Less commonly, the drug may cause life-threatening QTc prolongation.
Eribulin is sold by Eisai's U.S. subsidiary in Woodcliff Lake, N.J.Source: MedPage Today