FDA Lets Cancer Trial Resume after 3 Patient Deaths
By Damian Garde,
STAT
| 07. 12. 2016
Federal regulators on Tuesday gave Juno Therapeutics the all-clear to resume testing an experimental cancer treatment, just days after shutting down the trial because of three patient deaths.
Juno is at work in a newfangled field of oncology in which scientists remove a patient’s own white blood cells and rewire them to home in on cancerous growths, part of the growing field of immunotherapy. The Food and Drug Administration put the study on hold last week after three young leukemia patients who had received Juno’s experimental therapy developed fatal brain swelling.
Juno blamed the deaths on an unforeseen interaction between those reengineered blood cells, called CAR-Ts, and a chemotherapy drug used to prepare patients for treatment. It proposed resuming the trial without using that chemotherapy drug.
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