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).

"We are pleased the Office of Oncology Drug Products (OODP) chose to bring our pixantrone NDA back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs (OND) that we believe addresses the issues raised in the OODP Complete Response Letter of April 2010," stated James Bianco , chief executive of CTI, adding: "We believe the NDA demonstrates that pixantrone has a favorable benefit risk profile compared to standard chemotherapy in patients with relapsed or refractory aggressive NHL, a patient population for which there are no approved agents."