
The FDA investigates a "serious risk" of patients developing new cancers after CAR-T therapy. The agency has received reports of T-cell malignancies, including CAR-positive lymphoma, leading to hospitalization or death. The risk applies to all approved CAR-T therapies, with potential regulatory action pending. CD19 CAR-Ts like Yescarta, Tecartus, Kymriah, and Breyanzi are affected. While companies like Gilead, Novartis, and BMS express confidence in their therapies' safety profiles, the FDA's inquiry raises concerns about developing secondary malignancies in patients receiving CAR-T treatments.
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