The US Food and Drug Administration (FDA) has recently issued a significant warning concerning potential risks associated with a type of immunotherapy known as chimeric antigen receptor T-cell (CAR-T cell) therapy. Letters have been sent to various manufacturers instructing them to include a “boxed warning” in the prescribing information for these therapies.
This cautionary note highlights instances where T-cell malignancies have emerged after patients received BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. While the FDA acknowledges these risks, it underscores that the overall benefits of these products outweigh any potential downsides.
As of the latest update on Monday, the FDA has received reports of 25 cases of T-cell malignancies following CAR-T cell immunotherapies. T-cells, crucial components of CAR-T therapies, are modified in a lab to target cancer cells, and the modified cells are then reintroduced to the patient through an infusion.
Carly Pflaum, an FDA spokesperson, emphasizes the need for lifelong monitoring of patients undergoing these therapies for any signs of new malignancies. In the event of new malignancies, healthcare providers are advised to reach out to the manufacturer for guidance on sample collection and testing.
While the specific risk of developing treatment-induced T cell lymphoma post-CAR-T cell therapies is considered low, experts suggest that the updated safety label from the FDA is likely to spur the development of even safer versions of these therapies in the future.
In November, the FDA launched an investigation into the risk of secondary cancers associated with specific CAR-T cell therapies. By the end of last year, the agency had received reports of 22 cases of T-cell malignancies, with over 27,000 individuals having been treated with these therapies in the United States.
Despite acknowledging these risks, healthcare professionals stress that the substantial benefits of CAR-T cell therapies outweigh any potential drawbacks, particularly for patients dealing with relapsed or refractory blood cancers. The FDA intends to adapt and update its information as more data becomes available in the coming months. Keep an eye out for further developments in this evolving healthcare landscape.
