FDA lifts hold on cancer immunotherapy trial placed after patients died

BMJ 2016; 354 doi: (Published 18 July 2016) Cite this as: BMJ 2016;354:i3965
  1. Owen Dyer
  1. Montreal

The US Food and Drug Administration, which halted a trial of a promising but risky immunotherapy for acute lymphoblastic leukemia after hearing of the deaths of three young patients,1 has surprised observers by completing its review and lifting the clinical hold after just three days, in a process that usually takes months.

The FDA’s green light to Juno Therapeutics of Seattle to continue its trial of chimeric antigen receptor T cell (CAR-T) treatment is seen as a vote of confidence in the broader potential of cancer immunotherapy, a burgeoning field of research that was rocked earlier this week when Juno announced the three deaths from cerebral edema in the phase II “ROCKET” trial of its JCAR015 treatment.

CAR-T treatment involves removing T cells from the body, genetically engineering them …

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