title: U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma.
abstract: The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed systemic anaplastic large-cell lymphoma (sALCL). FDA analyzed the results of two single-arm trials, enrolling 102 patients with Hodgkin lymphoma and 58 patients with sALCL. Both trials had primary endpoints of objective response rate (ORR) and key secondary endpoints of response duration and complete response (CR) rate. For patients with Hodgkin lymphoma, ORR was 73% (95% CI, 65-83%); median response duration was 6.7 months, and CR was 32% (95% CI, 23-42%). For patients with sALCL, ORR was 86% (95% CI, 77-95%), median response duration was 12.6 months, and CR was 57% (95% CI, 44-70%). The most common adverse reactions were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting. FDA granted accelerated approval of brentuximab vedotin for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplantation (ASCT) or after failure of at least two prior multiagent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with sALCL after failure of at least one prior multiagent chemotherapy regimen.
authors.affiliation: Offices of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
authors.forename: R Angelo
authors.initials: RA
authors.lastname: de Claro
authors.forename: Karen
authors.initials: K
authors.lastname: McGinn
authors.forename: Virginia
authors.initials: V
authors.lastname: Kwitkowski
authors.forename: Julie
authors.initials: J
authors.lastname: Bullock
authors.forename: Aakanksha
authors.initials: A
authors.lastname: Khandelwal
authors.forename: Bahru
authors.initials: B
authors.lastname: Habtemariam
authors.forename: Yanli
authors.initials: Y
authors.lastname: Ouyang
authors.forename: Haleh
authors.initials: H
authors.lastname: Saber
authors.forename: Kyung
authors.initials: K
authors.lastname: Lee
authors.forename: Kallappa
authors.initials: K
authors.lastname: Koti
authors.forename: Mark
authors.initials: M
authors.lastname: Rothmann
authors.forename: Marjorie
authors.initials: M
authors.lastname: Shapiro
authors.forename: Francisco
authors.initials: F
authors.lastname: Borrego
authors.forename: Kathleen
authors.initials: K
authors.lastname: Clouse
authors.forename: Xiao Hong
authors.initials: XH
authors.lastname: Chen
authors.forename: Janice
authors.initials: J
authors.lastname: Brown
authors.forename: Lara
authors.initials: L
authors.lastname: Akinsanya
authors.forename: Robert
authors.initials: R
authors.lastname: Kane
authors.forename: Edvardas
authors.initials: E
authors.lastname: Kaminskas
authors.forename: Ann
authors.initials: A
authors.lastname: Farrell
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000079963:Brentuximab Vedotin; D017277:Drug Approval; D006689:Hodgkin Disease / Q000188:drug therapy*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D017730:Ki-1 Antigen / Q000276:immunology / Q000378:metabolism; D017728:Lymphoma, Large-Cell, Anaplastic / Q000188:drug therapy*; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D018796:Immunoconjugates; D017730:Ki-1 Antigen; D000079963:Brentuximab Vedotin