CTI's Pixuvri Strategy After FDA Rejection: Pursue Expanded Access, Start Combination Trial
This article was originally published in The Pink Sheet Daily
FDA's "complete response" letter follows ODAC's vote against the non-Hodgkin's lymphoma drug in March because CTI had insufficient data.
You may also be interested in...
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.
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.
Providing an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say