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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Episode guests

Saurabh Dahiya, MD, FACP

Jay Spiegel, MD

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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.

Introduction

2min

FDA Warning on Secondary Malignancies Post CAR T cell Therapy

13min

Exploring the Impact of Shifting CAR-T Therapies to Frontline Treatments and Study Findings

3min

Exploring Secondary Malignancies in CAR-T Therapy

11min

Exploring the Benefit-Risk Ratio of CAR-T Cell Therapy in Approved Settings

3min

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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The HemOnc Pulse

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

Episode guests

Podcast summary created with Snipd AI

Quick takeaways

Deep dives

The Impact of FDA Warnings on CAR-T Therapy

Black Box Warning and Label Changes

Clinical Impact and Research Considerations

Remember Everything You Learn from Podcasts