CTI BioPharma's IND for pacritinib placed on full clinical hold
CTI BioPharma Corp said that the US Food and Drug Administration (FDA) has placed a full clinical hold on its investigational latest drug application for pacritinib. The company said that it has taken back its application for the experimental blood cancer drug and is going to review the safety and efficacy data.
The regulator also suggested that CTI should request for a meeting before it submits its response to the full clinical hold.
Earlier on February 4, the FDA had put a partial hold on pacritinib, citing excess mortality and other bad events in pacritinib-treated patients.
As part of the full clinical hold, all patients on pacritinib should discontinue it right away and no patients can get enrolled or begin pacritinib as early or crossover treatment.
CTI has lately provided an update about the clinical studies being carried out under the Company's Investigational New Drug (IND) application for pacritinib.
After the issuance of the Company's February 8, 2016, press release that described the FDA-issued partial clinical hold about those clinical studies, the company has got an oral communication from the FDA followed by a letter notifying the Company that its IND for pacritinib has been put on full clinical hold.
CTI has taken back its New Drug Application (NDA) until it gets a chance to review the safety and efficacy data from the PERSIST-2 Phase 3 clinical trial and pan out further moves.
The February 8, 2016, letter of the FDA noted that the interim overall survival results from PERSIST-2 have shown a harmful effect on survival constant with PERSIST-1 results.
The life loss in PERSIST-2 in pacritinib-treated patients was caused by suffering from cardiac failure, intracranial hemorrhage and cardiac arrest.