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.

Get the full story on GeekWire.

About Alan Boyle

Award-winning science writer, creator of Cosmic Log, author of "The Case for Pluto: How a Little Planet Made a Big Difference," president of the Council for the Advancement of Science Writing. Check out "About Alan Boyle" for more fun facts.
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