title: FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen.
abstract: 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/m2intravenously (i.v.) on days 1 and 8 or dacarbazine 850, 1,000, or 1,200 mg/m2i.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.
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. christy.osgood@fda.hhs.gov.
authors.forename: Christy L
authors.initials: CL
authors.lastname: Osgood
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Meredith K
authors.initials: MK
authors.lastname: Chuk
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Marc R
authors.initials: MR
authors.lastname: Theoret
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lan
authors.initials: L
authors.lastname: Huang
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Kun
authors.initials: K
authors.lastname: He
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Leah
authors.initials: L
authors.lastname: Her
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Patricia
authors.initials: P
authors.lastname: Keegan
authors.affiliation: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage; D003606:Dacarbazine / Q000008:administration & dosage; D018572:Disease-Free Survival; D017277:Drug Approval; D005260:Female; D005663:Furans / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007659:Ketones / Q000008:administration & dosage* / Q000009:adverse effects; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008080:Liposarcoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D000095662:Polyether Polyketides
chemical_list: D018943:Anthracyclines; D003606:Dacarbazine; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides