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# FDA Full Clinical Hold on CTI BioPharma Drug
- URL: https://www.fdaweb.com/fda-full-clinical-hold-on-cti-biopharma-drug/
- Published: 2016-02-10T12:00:00.000Z
- Updated: 2026-09-15T02:34:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134734

> FDA has placed a full clinical hold on CTI BioPharma’s pacritinib clinical studies due to its “detrimental effect on survival.” Earlier this week, the company said a partial clinical hold was ordered on the myelofibrosis drug (see story) due to excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-1 trial.  
>  
> A recent letter from FDA notes that the interim overall survival results from PERSIST-2 show a detrimental effect on survival consistent with the results from PERSIST-1, according to the company. The deaths in PERSIST-2 in pacritinib-treated patients include intracranial hemorrhage, cardiac failure and cardiac arrest. The agency made recommendations for the company to conduct dose exploration studies for pacritinib in patients with myelofibrosis, submit final study reports and datasets for PERSIST-1 and PERSIST-2, revise relevant statements in the investigator's brochure and informed consent documents and making certain modifications to protocols. In addition, it recommends that the company request a meeting prior to submitting a response to full clinical hold.