Cell Therapeutics, Inc. announced that the U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial, provided two key matters can be satisfactorily resolved.
First, the submission of information regarding the circumstances surrounding the decision of stopping the trial early to assure that ongoing results assessment were not dictating the decision to stop and, second, ascertainment of the soundness of the primary endpoint after an additional independent radiologic review. If these two key matters are addressed satisfactorily, then PIX301 could be deemed successful, having achieved its primary and secondary endpoints and a re-review of safety and efficacy would be warranted.
OND denied the dispute appeal request to conclude that the efficacy of pixantrone has been demonstrated, but disagreed with the conclusion in the Complete Response Letter that PIX301 was a failed study, which warranted application of an interim analysis statistical thresholds.
“We are gratified and excited that based on a thorough review of our appeal arguments and NDA review that OND provided us the opportunity to re-submit the NDA for re-review and importantly that an additional clinical trial would not necessarily be required for accelerated approval should the two key matters raised be addressed satisfactorily,” said James A. Bianco PhD, chief executive officer of CTI. “This was the right decision in the interests of patients with relapsed refractory aggressive NHL beyond second line therapy for whom there are no approved or effective drugs.”
As a result of this development, the company plans to move quickly to request a meeting with the appropriate Division of the FDA’s Office of Oncology Drug Products and to submit the requested information, as well as all other relevant data requested in the Complete Response Letter, in a re-submission. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the re-submitted NDA would have a six month review cycle.
Release Date: May 3, 2011
Source: Cell Therapeutics, Inc.
Filed Under: Drug Discovery
