Johnson & Johnson Receives FDA Approval for Carvykti in Transplant-Eligible Frontline Myeloma

Johnson & Johnson today announced that the FDA has approved Carvykti (ciltacabtagene autoleucel) for the treatment of adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation. In the Phase 3 CARTITUDE-6 trial, Carvykti demonstrated a statistically significant improvement in progression-free survival versus VRd plus ASCT. This approval moves CAR-T cell therapy to the frontline setting in multiple myeloma, representing a paradigm shift in the treatment of this disease.