The FDA is investigating several reports of T cell malignancies, lymphoma and other adverse events in clinical trial patients who reported previously receiving certain CAR-T cell immunotherapies for treatment.
Specifically, B-cell maturation antigen (BCMA)-directed and CD19-directed chimeric antigen receptor — or CAR — T cell therapies are the two methods cited by the FDA that patients had received prior to the reports, according to the agency's Nov. 28 news release. The agency emphasized that patients who have received these therapies should now be monitored lifelong for future possible development of malignancies.
"Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action," the news release states.
If a patient does develop a malignancy or lymphoma following one of these therapeutic procedures, the FDA notes the manufacturer should be contacted and clinicians should also review instructions for gathering patient samples to test for the chimeric antigen receptor transgene.