The FDA has received reports linking T-cell malignancies, including CAR-positive lymphoma, to BCMA- or CD19-directed CAR T-cell treatments from clinical trials and postmarketing data.
Approved products like Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta are under investigation due to the risk.
In its announcement, the FDA stated that while the benefits of these products generally outweigh their risks, they’re actively investigating the risk of T-cell malignancies with severe outcomes, considering potential regulatory measures.
These therapies carry a labeled warning for potential secondary malignancies, leading to 15-year safety studies post-approval. Lifelong monitoring for new cancers after treatment is advised.
Patients should contact the manufacturer for further guidance and testing if a new malignancy occurs post-treatment
Source: FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous
