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.
The affected CAR T-cell immunotherapy products include:
“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, [the] FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalisation and death, and is evaluating the need for regulatory action,” the FDA said.
