A study published in Clinical Cancer Research found that second primary malignancies (SPMs) after CAR T-cell therapy are statistically comparable to those following other therapies. The FDA issued a warning on SPM risks after CAR T therapy based on data from the FDA Adverse Event Reporting System. However, the study suggests there is no increased risk compared to other standard-of-care therapies. Factors such as the number of prior treatments and follow-up duration may impact SPM risk. More research is needed to understand individual risk levels. The study emphasizes the importance of clear reporting standards for SPMs in clinical trials.
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