18 March 2024

Leukaemia is the most common second primary cancer reported among patients who have received CAR T-cell therapy, according to a major new analysis.

The study does not indicate whether second primary cancers are caused by the therapy, but gives the first indication of the range of these cancers, according to the study reported in Blood.

Researchers studied details of adverse events reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System, known as FAERS.

Out of 12,394 adverse events, 536 listed secondary malignancies (4.3%). T-cell malignancies represented a very small number of the adverse events, 19 in total, or 0.15%. Leukaemias represented 2.7% of the adverse event reports and skin cancers 0.4% .

Dr Magdi Elsallab of Massachusetts General Hospital, joint first-author of the study, said: “When compared to similar drugs, we observed a slight increase in reporting certain secondary cancers to the FDA after CAR T-cell products.

“We will continue to monitor the data released by the FDA to learn more about CAR-T-associated risks. However, it’s crucial to stress that the benefits of CAR T-cell therapies still outweigh the risks for the approved indications.”

Study leader Dr Marcela Maus said: “Patients receiving CAR T-cell therapy are often heavily pretreated with other drugs, which can also contribute to the development of secondary cancers.

“At this point, the risk of secondary cancers after CAR T-cell therapy cannot be definitively attributed to the CAR T cells as all of these patients received multiple prior chemotherapy agents that are known to elevate the risk of secondary cancers.”


Elsallab M, Ellithi M, Lunning MA, D’Angelo C, Ma J, Perales MA, Frigault MJ, Maus MV. (2024) “Second Primary Malignancies After Commercial CAR T Cell Therapy: Analysis of FDA Adverse Events Reporting System (FAERS).” Blood, doi: 10.1182/blood.2024024166

Link: https://ashpublications.org/blood/article/doi/10.1182/blood.2024024166/515310/Second-Primary-Malignancies-After-Commercial-CAR-T

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