Seattle-based Juno Therapeutics says it’s resuming a clinical trial of its immunotherapy treatment, a week after the Food and Drug Administration ordered a hold due to the deaths of three patients.
The FDA lifted its hold on the Phase II clinical trial for Juno’s first product, known as JCAR015, after the company removed a chemotherapy drug known as fludarabine from the treatment protocol. The deaths resulted from cerebral edema, or brain swelling, which was thought to have been caused by a toxic reaction to a drug combination including fludarabine.
Fludarabine was added to the pre-conditioning treatment regimen only recently. A different drug, known as cytoxan or cyclophosphamide, will continue to be used.
Now that the hold has been lifted, patients can once again be enrolled in the trial.