Risk/Benefit Of CAR-T For Autoimmune Diseases May Shift With FDA Investigation

Use Could Be Restricted To Most Severe Patients

 
• By Mandy Jackson
  
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CAR-T therapy-associated T-cell malignancies that the US FDA is investigating could make the treatments less attractive in autoimmune diseases than in oncology, but patients in both settings already accept some cancer risk with other available medicines.

3d illustration of cytotoxic CAR exosomes secreted by engineered T immune cells
CAR-T use in autoimmune diseases is just beginning • Source: Shutterstock

One of the initial reactions to news that the US Food and Drug Administration is investing reports of T-cell malignancies in patients treated with approved CD19- and BCMA-targeting chimeric antigen receptor T-cell (CAR-T) therapies for hematological malignancies was that CAR-T candidates being developed for autoimmune diseases could be derailed by the potential safety risk. However, many patients with autoimmune diseases and cancer already accept some risk of secondary malignancy.

Key Takeaways

  • The FDA’s investigation of T-cell malignancies associated with CAR-T products approved for blood cancers may impact the use of CAR-T therapies in autoimmune diseases.

Several well-known drugs for inflammatory diseases come with boxed warnings about potential cancer risks, including Humira (adalimumab) with a warning...

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