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FDA places full clinical hold on pacritinib
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The FDA has placed a full clinical hold on studies that involve pacritinib, an oral tyrosine kinase inhibitor in development for the treatment of patients with myelofibrosis.
Under the full clinical hold, all patients currently undergoing treatment with pacritinib (CTI BioPharma) must discontinue use immediately. No patients can be enrolled into trials or start pacritinib as initial or crossover treatment.
CTI BioPharma also has withdrawn its new drug application for pacritinib until safety and efficacy data from the PERSIST-2 trial can be reviewed. All clinical investigators involved with the trial have been notified about the full clinical hold.
PERSIST-2 — a randomized, controlled phase 3 trial — was designed to assess the efficacy and safety of pacritinib vs. best available therapy in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
A letter the FDA sent to CTI BioPharma on Feb. 8 noted the interim OS results from PERSIST-2 revealed a detrimental effect on survival with pacritinib, according to a CTI BioPharma-issued press release. In that trial, causes of death among pacritinib-treated patients included intracranial hemorrhage, cardiac failure and cardiac arrest.
The FDA — which had imposed a partial clinical hold on pacritinib on Feb. 4 — made several recommendations to the company, including conducting dose-exploration studies on pacritinib in patients with myelofibrosis, submitting final study reports and data sets for both the PERSIST-1 and PERSIST-2 studies, and making modifications to protocols.
Early-phase studies showed treatment with pacritinib resulted in minimal myelosuppression, according to the CTI BioPharma-issued press release.