Cell Therapeutics' Dual Strategy On Pixuvri Will Be Tested At Advisory Committee
This article was originally published in The Pink Sheet Daily
While appealing the “complete response” letter it got for its non-Hodgkin’s lymphoma treatment Pixuvri on the basis of re-analyzed data, Cell Therapeutics also is doing the additional combination trial the agency requested.
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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.
FDA's "complete response" letter follows ODAC's vote against the non-Hodgkin's lymphoma drug in March because CTI had insufficient data.
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.