The U.S. Food and Drug Administration placed a hold on a Juno Therapeutics clinical trial of a treatment for a form of leukemia following the death of two trial patients last week.
Juno said in a press release Thursday the deaths followed the introduction of fludarabine, a chemotherapy drug, into the pre-conditioning regimen.
The trial is the second phase of testing of JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, also known as the rocket trial.
The FDA hold is likely to impact Juno’s goal of getting JCAR015 approved as early as next year, Juno officials said on a conference call Thursday, soon after it released news of the FDA’s decision to suspend the trial.
Juno has proposed continuing the trial without fludarabine.
Juno, which is based in Seattle and develops cancer fighting immunotherapy technology, said its other trials are not affected by the FDA hold.
