USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe
The FDA’s required label update comes less than two months after the agency unveiled an investigation into secondary T-cell malignancies among patients who received BCMA- or CD19-targeted CAR-Ts.
For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed warning section of each product’s label, according to the agency’s separate notification letters dated Jan. 19 to Bristol Myers Squibb, Gilead Sciences’ Kite Pharma, Johnson & Johnson and Novartis. A black box warning is the most serious safety alert on a medication’s label.
More information on Fierce Pharma.
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vroby (24 juillet 2024). USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12365





