Six BCMA-directed, CD19-directed autologous CAR T-cell therapies are under investigation for the potential risk of T-cell malignancies.
Patients who have received B-cell maturation antigens (BCMA) or CD19-directed autologous chimeric antigen receptor (CAR) T-cell therapies were reported to have T cell malignancies and CAR-positive lymphoma, according to a press release from the FDA.
These reports also included CAR-positive lymphoma. The FDA was notified of this risk through clinical trials and/or adverse effects (AE) data collected after the conclusion of the trials. At this time, the FDA believes all patients who received the aforementioned treatments are at risk of T-cell malignancies.
The risk of T-cell malignancies occurred with several currently FDA-approved products, including:
The FDA has noted that the benefits of these products do outweigh the potential risks, but an investigation will occur. The agencyy will look into the occurrence of T cell malignancies with serious outcomes, such aslike hospitalizations or death. This will determine if there is a need for regulatory action.
The prescribing information for the above products does list the potential to develop secondary malignancies as this is a known AE with integrating vectors. When each of these products was initially approved, a 15-year long-term follow-up observational study was required. This occurred under the postmarketing requirements section 505(0) to assess long-term safety and the risk of secondary malignancies after treatment.
For patients who are currently receiving treatment or are participating in clinical trials, life-long monitoring should occur for these malignancies.
FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies. News release. FDA. November 28, 2023. Accessed November 29, 2023. https://bit.ly/47CkPYY