CTI's Pixuvri Strategy After FDA Rejection: Expanded Access, Combo Trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cell Therapeutics plans to pursue an expanded access program for its non-Hodgkin's lymphoma drug Pixuvri (pixantrone) while it conducts a new combination therapy trial to satisfy concerns raised in FDA's April 9 "complete response" letter
You may also be interested in...
Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows
By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show
Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows
By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show
Cell Therapeutics Should Consider Different Trial Design For Pixuvri, FDA's Pazdur Says
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.