FDA advisory to review Cell Thera's re-submitted pixantrone NDA

The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review Cell Therapeutics’ (Nasdaq: CTIC) re-submitted New Drug Application for pixantrone (proposed trade name Pixuvri) for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy on February 9.

Nearly two years ago, the ODAC issued a complete response letter to the company related to this NDA stating, in part, that CTI's prior clinical trial, PIX301, did not demonstrate efficacy, and that the company should conduct an additional clinical trial prior to approval. The company later appealed that decision (The Pharma Letters April 9 and December 6, 2010).