Johnson & Johnson's CARVYKTI® Receives FDA Approval as First BCMA-Targeted Therapy for Multiple Myeloma

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients 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. This approval marks a significant advancement as CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for multiple myeloma patients as early as first relapse. The FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, demonstrating a 59 percent reduction in the risk of disease progression or death compared to standard therapies. Dr. Binod Dhakal, Associate Professor at the Medical College of Wisconsin, hailed CARVYKTI's efficacy and the potential for a treatment-free period for multiple myeloma patients at first relapse, offering hope in managing this challenging disease.