Cell Therapeutics (CTI) has reported that on February 10, 2010, the FDA’s Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for Pixantrone, for the treatment of relapsed/refractory aggressive non-hodgkin’s lymphoma (NHL).
Pixantrone is a fast track designated product which has been accepted for review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
James Bianco, CEO of CTI, said: “The upcoming ODAC meeting is a very important milestone in the NDA review process and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team. As there are no other drugs currently approved in this setting, we believe that pixantrone would fulfill a significant unmet medical need for patients with relapsed/refractory aggressive NHL.”
However, at the ODAC meeting, committee members evaluate presentations of efficacy and safety data made by the pharmaceutical sponsor of the drug under review, FDA review staff, and occasionally third-party oncology experts in an open forum. Following the presentation, the committee members discuss questions posed by the Agency review staff and the meeting concludes with the committee voting on a recommendation to the FDA regarding approval.