FDA approves J&J’s CARVYKTI in refractory multiple myeloma

Johnson & Johnson announced that the U.S. Food and Drug Administration has approved CARVYKTI 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. With this approval, CARVYKTI becomes the first and only B-cell maturation antigen or BCMA-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse. FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of CARVYKTI reduced the risk of disease progression or death by 59 percent compared to standard therapies-pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone-in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The safety profile for CARVYKTI includes a boxed warning for Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, Parkinsonism and Guillain-Barre syndrome and their associated complications, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged and Recurrent Cytopenias and Secondary Malignancies including myelodysplastic syndrome, acute myeloid leukemia and T-cell malignancies. Warnings and Precautions include Increased Early Mortality, Hypogammaglobulinemia, Infections, Hypersensitivity Reactions and Effects on Ability to Drive and Use Machines.