Combining pixantrone (Pixuvri) with rituximab (Rituxan) failed to improve progression-free survival (PFS) compared with gemcitabine plus rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) enrolled in the phase III PIX306 trial, according to CTI BioPharma, the manufacturer of pixantrone.
CTI did not conduct an additional trial at the time. The company instead appealed the CRL and provided additional analysis of the EXTEND findings with its resubmission of its NDA to the FDA in October 2011. A second ODAC meeting was then set for February 9, 2012, to review CTI’s resubmitted NDA. However, on January 30, 2012, CTI announced that it had withdrawn its NDA after the FDA did not meet its request to reschedule the ODAC meeting to late March 2012.
- Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review. Published June 24, 2009. Accessed July 9, 2018. https://bit.ly/2u7Ab6V.
- 18-month Follow-up Data on Phase III Study of Pixantrone in Late Stage Relapsed or Refractory, Aggressive Non-Hodgkin's Lymphoma Continues to Demonstrate Significant Improvement in Complete Remission and Progression Free Survival Over Standard Chemotherapy. Published September 16, 2009. Accessed July 9, 2018. https://bit.ly/2m2TJFd
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