Pacritinib put on FDA hold
- Feb 10, 2016
Author: George D. Turner, PharmD
The trial drug pacritinib (in development by CTI BioPharma) has been placed on full clinical hold by the FDA due to concerns over the safety of the drug. Analysis of data from clinical trials that were ongoing show a detrimental effect on survival and patient deaths from causes including intracranial hemorrhage, cardiac failure and cardiac arrest.
This affects all pacritinib clinical trials. A full clinical hold means all patients currently on pacritinib must discontinue pacritinib immediately and no new patients can be enrolled in trials to receive pacritinib or can crossover from placebo.