The agency sent letters to six pharmaceutical makers of the products on Jan. 19 detailing the safety related labeling changes.
The drugmakers must now include boxed warnings stating “T cell malignancies have occurred following treatment with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies.” Medication guides and patient counseling are also now required.
The therapy products affected by the new labeling requirements include: Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta.
The drugmakers have 30 days to comply with the new regulations.
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