title: FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma.
abstract: On November 30, 2015, the FDA approved elotuzumab (Empliciti; Bristol-Myers Squibb) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who received one to three prior therapies. FDA approval was based primarily on the results of a phase III, randomized, open-label, multicenter trial, CA204004, which evaluated elotuzumab in combination with lenalidomide and dexamethasone (E-Ld) compared with lenalidomide and dexamethasone (Ld) alone in patients with relapsed or refractory multiple myeloma. Coprimary endpoints were progression-free survival (PFS) and overall response rate (ORR). The key secondary endpoint was overall survival, but these data were not mature at the time of clinical database cutoff. The trial demonstrated a statistically significant improvement in PFS, with an estimated HR of 0.70 for E-Ld over Ld [95% confidence interval (CI), 0.57-0.85;P= 0.0004). Estimated median PFS was 19.4 months in the E-Ld arm and 14.9 months in the Ld arm. ORR was 75.8% in the E-Ld arm compared with 65.5% in the Ld arm. Serious adverse reactions were reported in 65% of patients in the E-Ld arm compared with 57% in the Ld arm. The FDA approved elotuzumab with the following warnings and precautions: infusion reactions, infections, second primary malignancies, hepatotoxicity, and interference with the determination of complete response.Clin Cancer Res; 23(22); 6759-63. ©2017 AACR.
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Nicole.Gormley@fda.hhs.gov.
authors.forename: Nicole J
authors.initials: NJ
authors.lastname: Gormley
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Chia-Wen
authors.initials: CW
authors.lastname: Ko
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Albert
authors.initials: A
authors.lastname: Deisseroth
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lei
authors.initials: L
authors.lastname: Nie
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Edvardas
authors.initials: E
authors.lastname: Kaminskas
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Natasha
authors.initials: N
authors.lastname: Kormanik
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Kirsten B
authors.initials: KB
authors.lastname: Goldberg
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Ann T
authors.initials: AT
authors.lastname: Farrell
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D003907:Dexamethasone; D017277:Drug Approval; D019008:Drug Resistance, Neoplasm; D006801:Humans; D000077269:Lenalidomide; D015337:Multicenter Studies as Topic; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D013792:Thalidomide / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C546027:elotuzumab; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide