title: The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human use.
abstract: On May 10, 2012, the European Commission issued a conditional marketing authorization valid throughout the European Union for pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma (NHL). Pixantrone is a cytotoxic aza-anthracenedione that directly alkylates DNA-forming stable DNA adducts and cross-strand breaks. The recommended dose of pixantrone is 50 mg/m(2) administered on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. In the main study submitted for this application, a significant difference in response rate (proportion of complete responses and unconfirmed complete responses) was observed in favor of pixantrone (20.0% vs. 5.7% for pixantrone and physician's best choice, respectively), supported by the results of secondary endpoints of median progression-free and overall survival times (increase of 2.7 and 2.6 months, respectively). The most common side effects with pixantrone were bone marrow suppression (particularly of the neutrophil lineage) nausea, vomiting, and asthenia. This article summarizes the scientific review of the application leading to approval in the European Union. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu).
authors.affiliation: European Medicines Agency, London, United Kingdom. elias.pean@ema.europa.eu
authors.forename: Elias
authors.initials: E
authors.lastname: Péan
authors.forename: Beatriz
authors.initials: B
authors.lastname: Flores
authors.forename: Ian
authors.initials: I
authors.lastname: Hudson
authors.forename: Jan
authors.initials: J
authors.lastname: Sjöberg
authors.forename: Kristina
authors.initials: K
authors.lastname: Dunder
authors.forename: Tomas
authors.initials: T
authors.lastname: Salmonson
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
authors.forename: Edward
authors.initials: E
authors.lastname: Laane
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
mesh_terms: D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage* / Q000737:chemistry; D017277:Drug Approval; D005062:European Union; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000473:pathology; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D015201:Meta-Analysis as Topic; D012008:Recurrence; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D007546:Isoquinolines; C086548:pixantrone
keywords: Aggressive non-Hodgkin's lymphoma; EMA; European Medicines Agency; Pixantrone; Pixuvri