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.