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Juno revises, resumes cancer trial after deaths

Image: Juno lab
Inside Juno Therapeutics’ lab, employees work with a patient’s genetically engineered T-cells and prepare them for infusion. (Credit: Juno Therapeutics)

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.

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