Part Two: Drs. Dahiya, Spiegel Return to Discuss 'Black Box' Warning on CAR-T Therapies
Feb 29, 2024
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In this podcast, Drs. Dahiya and Spiegel discuss the FDA's 'Black Box' warning on CAR-T therapies for blood cancer patients. They explore the risks of secondary malignancies post-treatment and the impact of shifting CAR-T therapies to frontline treatments. The speakers stress the importance of informed consent, patient counseling, and evaluating the benefit-risk ratio in oncology treatments.
FDA mandated black box warning for CAR-T therapies due to T-cell malignancy risk post-treatment.
Despite risks, clinicians highlight survival benefits of CAR-T therapy for chemo-refractory patients.
Deep dives
The Impact of FDA Warnings on CAR-T Therapy
Following FDA warnings in November 2023 regarding secondary malignancies after CAR-T cell therapy, subsequent investigations revealed 22 cases of T-cell lymphoma post-treatment. Concerns arise regarding the direct link between CAR-T therapy and these malignancies, especially with emerging cases of T-cell lymphoma testing positive for CAR transgenes.
Black Box Warning and Label Changes
The FDA mandated a black box warning for commercial CAR-T therapies due to the risk of T-cell malignancies post-treatment. Manufacturers are expected to update labels to reflect these concerns. Additionally, the FDA emphasizes the need for long-term patient follow-up and encourages reporting to gauge the true extent of these secondary malignancies.
Clinical Impact and Research Considerations
Despite the black box warning, the benefit-risk ratio for administering CAR-T therapy in approved settings remains favorable. Research efforts focus on understanding clonal hematopoiesis and inflammatory responses post-CAR-T treatment. While acknowledging the risks associated with secondary malignancies, clinicians emphasize the overall survival benefits of CAR-T therapy in treating chemo-refractory patients.
Saurabh Dahiya, MD, FACP, of Stanford Medicine, and Jay Spiegel, MD, of the University of Miami, join The HemOnc Pulse for the second half of a two-part series on reports regarding secondary T-cell malignancies in patients after being treated with a chimeric antigen receptor (CAR) T-cell therapy and updates from the US Food and Drug Administration (FDA) on the issue.
Drs. Dahiya and Spiegel return to the show shortly following the announcement that the FDA sent requests to drug manufacturers on January 9 to update prescription labels with "Black Box" warnings on the six CAR-T therapies used to treat blood cancers.
Part one of the series covers the FDA's initial report in November 2023 and why it set off a "firestorm" in the hematology-oncology community.
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