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.
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TG, which has seen growing sales for Briumvi in multiple sclerosis, is expanding into CAR-T for immunology as Precision pivots to in vivo gene therapies.
The allogeneic CAR-T developer announced a significant shift in its business strategy to develop its lead candidate in first-line consolidation of LBCL as the third-line disease setting becomes saturated.
They have new data for the CAR-T after one to three lines of multiple myeloma treatment and Phase III patient-reported outcomes data, but Gilead and Gracell are nipping at the companies’ and BMS’s heels.