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The HemOnc Pulse

Part Two: Drs. Dahiya, Spiegel Return to Discuss 'Black Box' Warning on CAR-T Therapies

Feb 29, 2024
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.
32:03

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Quick takeaways

  • 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.

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