FDA: Safety Label Changes Required for BCMA-, CD19-Directed CAR T-Cell Therapies

The Food and Drug Administration (FDA) is requiring new safety information be included in the labeling for all B-cell maturation antigen (BCMA)- or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies.

The updates were prompted by findings from an investigation of reports describing mature T-cell malignancies among patients treated with these therapies. The classwide labeling changes apply to the following products: Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), and Yescarta (axicabtagene ciloleucel).

According to the FDA, the risk of T-cell malignancy is applicable to all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. To prepare these treatments, a patient’s own T-cells are reprogrammed with a transgene encoding a CAR that identifies and eliminates BCMA or CD19-expressing target cells. The risk of secondary malignancy is believed to be related to the viral vectors used to transfer the genetic material.

Given the serious risk, the FDA is requiring the following safety labeling changes:

• In the Boxed Warning, the inclusion of language stating that T-cell malignancies have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.
• An update to the Warnings and Precautions section for secondary malignancies to note that T-cell malignancies have occurred following treatment with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.
• Updates to the Patient Counseling Information and the Medication Guide related to the risk of secondary malignancies, including T-cell malignancies.

New malignancies should be reported to the product manufacturer and to the FDA’s MedWatch program.

This article originally appeared on MPR