Cell Therapeutics appeals FDA decision on pixantrone NDA for non-Hodgkin's lymphoma

USA-based Cell Therapeutics (Nasdaq and MTA: CTIC) says that it has submitted a formal appeal to the Office of New Drugs in the US Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the Pixuvir (pixantrone) New Drug Application to treat relapsed/refractory aggressive non-Hodgkin's lymphoma (The Pharma Letter April 9).

CTI had requested accelerated approval of its pixantrone NDA for a patient group for which there are no drugs currently approved in this clinical setting. The Office of Oncology Drug Products 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 CTI should conduct an additional clinical trial prior to approval. Although CTI is preparing to initiate its PIX306 trial, which would serve as either a post-approval confirmatory trial or a second registration trial for approval, the firm has filed an appeal under the FDA's formal dispute resolution process asking the Office of New Drugs to conclude that PIX301 demonstrated efficacy.

FDA “diverged from accepted statistical principles”