Johnson & Johnson Receives FDA Approval for Carvykti in Earlier Lines of Multiple Myeloma

Johnson & Johnson today announced that the FDA has approved Carvykti (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In the Phase 3 CARTITUDE-4 trial, Carvykti demonstrated a statistically significant improvement in progression-free survival compared to standard of care. The 12-month PFS rate was 75.9% for Carvykti versus 48.6% for standard of care. This approval expands Carvykti's use into earlier lines of multiple myeloma treatment.