FDA issues warning about risk of T-cell malignancies after CAR T-cell therapy
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The FDA published a safety advisory on the risk of T-cell malignancies among individuals receiving autologous chimeric antigen receptor T-cell therapy for the treatment of certain blood cancers.
The warning pertains to CD19-directed therapies approved for the treatment of various advanced and high-risk forms of non-Hodgkin lymphoma and B-cell maturation antigen (BCMA)-directed agents for multiple myeloma. The FDA received reports of T-cell malignancies among CAR-T recipients from clinical trials and as a part of the postmarketing adverse event monitoring requirements for each commercially approved therapy.
Multiple approved agents in the class have produced T-cell malignancies, the FDA advised. The list includes idecabtagene vicleucel (Abecma, Bristol Myers Squibb, 2seventy bio), lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb), ciltacabtagene autoleucel (Carvykti; Janssen, Legend Biotech), tisagenlecleucel (Kymriah, Novartis), brexucabtagene autoleucel (Tecartus, Kite Pharma/Gilead Sciences) and axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead Sciences).
“The overall benefits of these products continue to outweigh their potential risks for their approved uses,” the FDA said in a press release. “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 FDA notice is light on details to help inform clinicians about the potential risk, according to Marcela V. Maus, MD, PhD, director of the cellular immunotherapy program at Mass General Cancer Center and a Healio | HemOnc Today Associate Medical Editor.
“It is not clear how frequently this occurs, but it seems to be quite rare, and it’s not clear whether all the cases are arising from the CAR-T cells themselves, as opposed to an independent T-cell lymphoma,” Maus told Healio. “I think there is a general sense of surprise in the field about this announcement, along with uncertainty about whether there will be any actions taken other than further discussion and investigation.”
Prescribing information for CAR-T carries a warning for secondary malignancies related to BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.
Anyone receiving these treatments should be monitored for new malignancies throughout their lifetime, the FDA said. It also advised that treating physicians contact the agent’s manufacturer if a new malignancy forms in a patient or clinical-trial participant receiving these products.
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