Cell Therapeutics Should Consider Different Trial Design For Pixuvri, FDA's Pazdur Says
This article was originally published in The Pink Sheet Daily
The odds were against Cell Therapeutics from the beginning of the Oncology Drugs Advisory Committee meeting, as FDA officials had concluded that the single, incomplete clinical trial did not provide enough evidence of efficacy.
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Despite a sizeable price cut, uncertainty surrounding CTI’s non-Hodgkin’s lymphoma therapy Pixuvri has landed it with a second NICE rejection.
In an early stage decision, NICE rejects Pixuvri for multiply relapsed or refractory aggressive non-Hodgkin's lymphoma, citing lack of evidence and cost-effectiveness.
Company’s announcement that it pulled the NDA for its investigational non-Hodgkin’s lymphoma treatment comes after the sponsor would have received FDA’s background briefing document for the Feb. 9 Oncologic Drugs Advisory Committee meeting.