Second primary malignancies after commercial CAR T-cell therapy: analysis of the FDA Adverse Events Reporting System
Magdi Elsallab, Moataz Ellithi, Matthew A. Lunning, Christopher R. D’Angelo, Jihyun Ma, Miguel‐Angel Perales, Matthew J. Frigault, Marcela V. Maus
Abstract
ABSTRACT: Second primary malignancies were reported in 536 of 12 394 (4.3%) adverse event reports following chimeric antigen receptor T-cell therapies in the Food and Drug Administration Adverse Event Reporting System. Myeloid and T-cell neoplasms were disproportionately more frequently reported, warranting further follow-up.
Topics & Concepts
Adverse Event Reporting SystemAdverse effectMedicineFood and drug administrationChimeric antigen receptorOncologyInternal medicinePharmacologyCancerImmunotherapyCAR-T cell therapy researchBiomedical and Engineering Education