Cell Therapeutics, Inc. has announced that results from its PIX301 phase 3 clinical trial of Pixuvri® (pixantrone) have been published online in The Lancet Oncology.
The publication authored by Ruth Pettengell, M.D., et al, is titled "Phase 3 Trial Comparing Pixantrone Dimaleate with other Chemotherapeutic Agents as a Single-agent, Salvage Treatment in Patients with Relapsed or Refractory Aggressive non-Hodgkin Lymphoma."
The results of the PIX301 clinical trial were the basis for conditional marketing authorization of Pixuvri in the European Union ("EU") as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL").
Pixuvri, is the first and only approved treatment in the EU in this patient setting as was announced on May 10, 2012.
The publication and editorial comments are available at http://www.thelancet.com/journals/lanonc/onlinefirst.
"The results of the PIX301 trial support the use of the Pixuvri for these patients and with the recent conditional marketing authorization in the EU we look forward to having this new, novel drug as an option in the EU to address this serious unmet medical need," stated Dr. Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX301 trial and lead author on the publication.
"With conditional marketing authorization by the European Commission earlier this month we are currently implementing our launch plan in the EU to provide access to Pixuvri for these patients as soon as possible," said James A. Bianco, M.D., CEO of CTI.