In a stunner, FDA immediately drops its hold on Juno’s lead CAR-T
So much for bureaucracy. In what may well be the shortest high-profile FDA clinical hold in the agency’s history, Juno reported today that the FDA has lifted the halt on its lead CAR-T program, satisfied that it found the cause for three patient deaths.
Juno confounded investors last week when it reported the deaths and the surprising hold, citing the recent addition of the chemotherapy agent fludarabine to its preconditioning of patients as a likely culprit. Some experts, who had used the drug in other studies to help clear the path for a followup therapy, publicly questioned the rationale. But the agency had no problem providing a quick green light to resume the pivotal study.
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