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.

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.