FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies:

The FDA is investigating reports of T-cell malignancies, including CAR-positive lymphoma, in patients treated with BCMA- or CD19-directed autologous CAR T cell immunotherapies. These reports stem from both clinical trials and postmarketing data. All currently approved BCMA-directed and CD19-directed autologous CAR T cell immunotherapies are under scrutiny, including products like Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta.

While the benefits of these therapies still outweigh the risks for their approved uses, the FDA is taking the T-cell malignancy risk seriously due to its potential for serious outcomes, such as hospitalization and death. Long-term safety studies are mandated to assess the risk of secondary malignancies over a 15-year period.

Patients and clinical trial participants receiving these treatments should undergo lifelong monitoring for new malignancies. If a new malignancy occurs post-treatment, contacting the manufacturer is advised to report the event and obtain instructions for testing for the presence of the CAR transgene.