Pixantrone (Pixuvri®) is an aza-anthracenedione with a novel mode of action that is conditionally approved in the EU for use as monotherapy in adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma (NHL). In the randomized, open-label, multinational, phase 3 PIX301 trial in patients with multiply relapsed or refractory aggressive NHL, the complete response (CR) plus unconfirmed CR (uCR) rate at the end of treatment (primary endpoint) was significantly higher with intravenous pixantrone monotherapy than with a single-agent comparator (vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone or gemcitabine). Post hoc analysis also demonstrated a significantly higher CR/uCR rate in the subgroup of patients with centrally confirmed aggressive B-cell NHL who were receiving pixantrone versus a comparator agent as third- or fourth-line therapy. Pixantrone was generally well tolerated in PIX301, with a manageable adverse event profile. In conclusion, pixantrone is a useful option in patients with multiply relapsed or refractory aggressive B-cell NHL. Further results examining the use of pixantrone in combination with rituximab in patients previously treated with rituximab-containing regimens are awaited with interest.
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During the peer review process, the manufacturer of pixantrone was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflict of interest
Gillian Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
The manuscript was reviewed by: C. Gisselbrecht, Institut d’Hématologie Hopital Saint Louis, Paris, France; R. Herbrecht, Department of Oncology and Hematology, Hôpital de Hautepierre and Université de Strasbourg, Strasbourg, France; P.L. Zinzani, Institute of Hematology “Seragnoli”, University of Bologna, Bologna, Italy.
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Keating, G.M. Pixantrone: A Review in Relapsed or Refractory Aggressive Non-Hodgkin’s Lymphoma. Drugs 76, 1579–1586 (2016). https://doi.org/10.1007/s40265-016-0650-8
- Left Ventricular Ejection Fraction
- Overall Response Rate
- International Prognostic Index