FDA investigates secondary malignancy risk with CAR T-cell therapy
The TGA said it would take 'prompt regulatory action as appropriate' if any safety issues were confirmed.
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The TGA is closely watching an overseas investigation of chimeric antigen receptor T-cell therapies after reports of secondary malignancies in treated patients.
Last month, the US Food and Drug Administration (FDA) issued a safety advisory on the risk of T-cell malignancies, including chimeric antigen receptor (CAR)-positive lymphomas, in those exposed to the immunotherapies.