FDA probes 22 reports of blood cancer after CAR-T therapy

The FDA is looking into 22 reports of patients contracting blood cancer after receiving CAR-T therapy treatment. The move comes after the agency reported initial investigation efforts into cases in November. 

At a Jan. 8 Al­liance for Re­gen­er­a­tive Med­i­cine event in San Francisco, Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, shared additional details into the agency's ongoing efforts. 

Of the 22 cases being investigated, Dr. Marks noted that "the on­set of these was soon enough af­ter the ad­min­is­tra­tion, in some cas­es, that it does look like there's a causal re­la­tion­ship." 

In its November notice regarding the issue, the agency wrote that while overall the CAR-T therapy likely has benefits that outweigh potential risks, the risks it has been seeing are serious, ranging from hospitalization to death.

"Al­though se­quenc­ing is not avail­able for all of them, in at least a few of the cas­es we know that the CAR con­struct is in the ma­lig­nant clone, which re­al­ly sug­gests that there was prob­a­bly an as­so­ci­a­tion there," Dr. Marks said.

Dr. Marks said that while the findings from the investigation will still highlight the therapy's overall benefits in comparison to the adverse effects, it may lead the FDA to eventually issue further safety monitoring and guidance for the therapy.

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