TSVT - FDA Mandates Boxed Warning For Bristol Myers Johnson & Johnson CAR-T-Based Blood Cancer Therapies | Benzinga
Following an investigation announced in November last year, the FDA said on Thursday that it would now require boxed warnings—the highest safety-related caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies.
According to the agency, these blood cancer treatments may pose a risk of secondary cancers.
The health regulator has required related updates to other label sections, such as warnings and precautions, postmarketing experience, patient counseling information, and medication guides.
The agency said patients and clinical trial participants receiving treatment with these products should be monitored ...