Pixantrone maleate for non-Hodgkin's lymphoma.

Pixantrone (BBR-2778) is a novel aza-anthracenedione anthracycline derivative developed by Cell Therapeutics Incorporated, WA, USA. Pixantrone is similar in structure to the anthracenedione mitoxantrone but lacks the 5, 8-dihydroxy substitution groups implicated in mitoxantrone-induced cardiotoxicity. The PIX301 phase III single-agent trial of pixantrone for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma randomized patients to receive either pixantrone or another single agent of the investigators' choice. The rate of confirmed and unconfirmed remissions in patients treated with pixantrone was significantly higher than in those receiving other agents, as was the overall response rate and progression-free survival. There is evidence that pixantrone is well tolerated when substituted for anthracyclines in combination regimens for aggressive non-Hodgkin's lymphoma with comparable rates of complete remission. Pixantrone has also been used for the treatment of indolent non-Hodgkin's lymphomas and the combination of pixantrone and rituximab has been shown to be superior to rituximab alone in relapsed or refractory disease in the phase III PIX302 study. On the basis of these data, the United States Food and Drug Administration is considering pixantrone for use in adult patients with relapsed or refractory aggressive and indolent non-Hodgkin's lymphoma on a fast-track basis.