MedCity News November 28, 2023
CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
The FDA is investigating whether CAR T-therapies—cell therapies approved for treating advanced cases of blood cancer—are sparking secondary cases of cancer.
The agency announced Tuesday that it has received reports of T-cell malignancies in patients who received treatment with a cell therapy. These reports come from clinical trials or adverse event reports after these products reached the market.
The FDA did not specify which cell therapies...
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