Feb 9 (Reuters) – CTI BioPharma Corp said the U.S Food and Drug Administration has put a full clinical hold on the company’s investigational new drug application for pacritinib.
CTI said it has withdrawn its application for the experimental blood cancer drug and will now review the safety and efficacy data.
The regulator also recommended that CTI request a meeting prior to submitting its response to the full clinical hold.
The FDA had earlier put a partial hold on pacritinib on Feb. 4, citing excess mortality and other adverse events in pacritinib-treated patients.
Under full clinical hold, all patients currently on pacritinib must discontinue it immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment.
(Reporting by Shivam Srivastava in Bengaluru; Editing by Sunil Nair)