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.

Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.

Novartis pioneered CAR-Ts for leukemia and lymphoma, and inspired by pioneering physician Georg Schett, it also hopes to be first in the race to revolutionize autoimmune disease treatment with the therapies, and has unveiled the first clinical data for its candidate.

Multiple gene therapies have been approved in the last couple of years, but market access and reimbursement for gene therapies remain challenging – a key theme of the Cell & Gene Meeting on the Mesa.