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

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.

Of the labeling request, Dr. Dahiya said he found it “surprising.”

“It was somewhat surprising that the T-cell part went on the label without further investigation [into] if [the malignancy] is truly related or not,” he said.

No other therapy has been put “under the lens” in the same way CAR-T has, Dr. Dahiya noted.

“I don’t remember any other therapy where the patients are being studied in 10 different directions or with five different specialties in the hospital,” he said. “The more you look, the more you find, and that’s the right approach. I think we should zoom out.”

Dr. Spiegel said the warnings have not affected his treatment approach.

“I don’t think that these warnings change whether I’m going to offer CAR-T to someone, but I’m definitely going to have an informed consent discussion about the risks as well,” he said.

Dr. Dahiya agreed, noting that the benefit-risk ratio still favored CAR-T therapy in the current indications.

“The overall benefit-risk ratio of administering CAR-T in the approved setting we are in right now still remains unequivocally in favor of administering CAR T-cell therapy,” he said.

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.