EU approves Halaven (eribulin) for adult patients with unresectable liposarcomas- Eisai

The European Commission has approved Halaven (eribulin), from Eisai, for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. The approval is based on data from a Phase III study (Study 309) comparing the efficacy and safety of the drug to dacarbazine in 452 adults with leiomyosarcomas or liposarcomas, and showed a median overall survival improvement of 2.6 months (13.5 months versus 11.5 months, respectively). Data were published in The Lancet. In addition, a subset of patients given Halaven lived a median 7.2 months longer than those treated with dacarbazine (15.6 months versus 8.4 months median). There were no new safety signals shown in the trial.

Comment: Liposarcoma (adipocytic soft tissue sarcoma) refers to tumors that arise from fat cells and can occur anywhere in the body. Liposarcomas make up approximately 17% of all cases of soft tissue sarcoma, accounting for about 2,000 new cases each year.