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news.Cell Therapeutics (CTI) 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 Pixantrone new drug application (NDA) to treat relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
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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 has issued a Complete Response Letter to CTI 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, CTI has filed an appeal under the FDA’s formal dispute resolution process asking the Office of New Drugs to conclude that PIX301 demonstrated efficacy.
Cardiff University School of Pharmacy honorary visiting professor Richard Kay said that they believe the FDA diverged from accepted statistical principles and practices when the FDA applied a more stringent statistical significance level in concluding that the PIX301 primary analysis required an adjustment for type 1 error as if an interim analysis had been conducted.
"We believe the results of the PIX301 clinical trial should be analysed with the appropriate threshold that is standard for trials of this type in which only one efficacy analysis was conducted," Kay said.