FDA Places Clinical Hold on Juno Trials Following Three Deaths

The FDA has hit the brakes on Juno Therapeutics’ Phase 2 trial for a cancer candidate after three patients died from cerebral edema.

The study, which assessed the drug candidate in patients with relapsed or refractory B cell acute lymphoblastic leukemia, resulted in one death in May and two more in late June. This led the agency to put a clinical hold on the trial pending review, the company disclosed last week.

Juno officials speculate that the cause of the patient deaths was the addition of the leukemia drug fludarabine, which was used to prepare some trial participants for the treatment and could have acted as a dose amplifier.