The clinical trial of a new drug to treat blood cancer was shut down by the FDA after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest," according to the Seattle Times.
According to a company press release, "under the full clinical hold, all patients currently on pacritinib must discontinue pacritinib immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment."
It was not immediately clear how many deaths occurred.
The FDA originally put a partial hold on the clinical trial before the company received an oral communication followed by a letter that upgraded the hold, according to the report.
"The company intends to work together with the FDA and expects to submit modifications and revisions that address the recommendations noted above," the company explained in a previous statement, before the trial was halted. "In its written notification, the FDA cited the reasons for the partial clinical hold were that there was excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-1 trial."
The company said in their newest statement that they have withdrawn their New Drug Application with the FDA.
