The FDA has approved ciltacabtagene autoleucel for earlier use in certain adults with relapsed or refractory multiple myeloma. Ciltacabtagene autoleucel (Carvykti; Janssen, Legend Biotech), also known as cilta-cel, is a B-cell maturation antigen (BCMA)-directed CAR T cell therapy previously approved for use in adults with relapsed or refractory multiple myeloma after four lines of treatment. The expanded indication allows treatment with chimeric antigen receptor T cells after the first relapse and applies to lenalidomide-refractory adults who have received at least one prior line of treatment, including a proteasome inhibitor and an immunomodulatory agent. In the Phase 3 CARTITUDE-4 trial, Cilta-cel reduced disease progression or death by 59% when used as a prior line of treatment compared with standard therapy. Patients in the cilta-cel group had a higher total mortality rate than standard treatment, including mortality in the first 10 months after randomization to treatment, but still presented a positive risk-benefit analysis in the eyes of the Committee.
