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.
Risk/Benefit Of CAR-T For Autoimmune Diseases May Shift With FDA Investigation
Use Could Be Restricted To Most Severe Patients
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.

More from Immuno-oncology
BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
Merck expects Keytruda to come under Medicare price controls in 2028, but an analyst said the subcutaneous version could shield revenues for the franchise.
J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.
Increasingly focused on maximizing and accelerating the progress of its PD-L1 x VEGF inhibitor BNT357, the company expects new partnerships to be announced this year.
More from Anticancer
Merck expects Keytruda to come under Medicare price controls in 2028, but an analyst said the subcutaneous version could shield revenues for the franchise.
J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares