FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma who have Received a Prior Anthracycline-Containing Regimen

On January 28, 2016, the FDA approved eribulin (Halaven; Eisai Inc.) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. The approval was based on results from a single, randomized, open-label, active-controlled trial (Trial E7389-G000-309) enrolling 452 patients with advanced, locally recurrent or metastatic liposarcoma or leiomyosarcoma. Patients were randomized to eribulin 1.4 mg/m 2 intravenously (i.v.) on days 1 and 8 or dacarbazine 850, 1,000, or 1,200 mg/m 2 i.v. on day 1 of a 21-day cycle. There was a significant improvement in overall survival [OS; HR, 0.75; 95% confidence interval (CI), 0.61–0.94; P = 0.0119, stratified log-rank] for the overall population. Estimated median OS was 13.5 months (95% CI, 11.1–16.5) in the eribulin arm and 11.3 months (95% CI, 9.5–12.6) in the dacarbazine arm (HR, 0.75; 95% CI, 0.61–0.94; P = 0.011).There were no differences in PFS for the overall population. The effects of eribulin were limited to patients with liposarcoma ( n = 143) based on preplanned, exploratory subgroup analyses of OS (HR, 0.51; 95% CI, 0.35–0.75) and progression-free survival (PFS; 0.52; 95% CI, 0.35–0.78). Response rates in both treatment arms were less than 5% in the overall population and in the liposarcoma subgroup. The safety profile was similar to that previously reported for eribulin. The FDA determined that, based on the data reviewed, the benefit–risk assessment for eribulin is positive for patients with advanced, pretreated liposarcoma. Clin Cancer Res; 23(21); 6384–9. ©2017 AACR .