Setbacks

Scoop: J&J confirms that the FDA put AML drug on complete hold

J&J tells Endpoints News that a bispecific antibody it is partnered on with Genmab for acute myeloid leukemia has been put on clinical hold after patients in the trial suffered serious adverse events.

The drug, JNJ-63709178, targets both CD3 and CD123 and was in an early stage study when the hold was instituted, forcing investigators to suspend patient recruitment, according to the clinicaltrials.gov web site. The complete hold, which should stop dosing, followed.

A spokesperson for J&J confirmed the news, but declined to say just what adverse events were seen in the study.

“Janssen R&D temporarily suspended the study on Aug 8; the FDA put it on complete clinical hold effective Aug 16,” says the company spokesperson.  “We’re working with the FDA now to address recommended changes to the study.  At this point, we don’t have any additional details to share.  We’re hoping to resume the study with appropriate guidance from the FDA.”

News of the clinical hold was first raised in a tweet from Evaluate Pharma’s Jacob Plieth.


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