Part Two: Drs. Dahiya, Spiegel Return to Discuss 'Black Box' Warning on CAR-T Therapies
The HemOnc Pulse
FDA Warning on Secondary Malignancies Post CAR T cell Therapy
The chapter delves into the FDA's warning on the development of secondary malignancies after CAR T cell therapy, with a focus on T cell lymphoma cases. It discusses the investigation initiated by the FDA, recent cases of CAR-positive lymphoma post therapy, and the black box warning placed on approved CAR-T therapies for T-cell malignancy risk. The speakers stress the importance of staying informed, patient counseling, and proposed label changes in response to safety concerns.
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