Legend’s CARVYKTI approved by FDA for second-line treatment of multiple myeloma

Legend Biotech announced the U.S. Food and Drug Administration has approved CARVYKTI for the treatment of 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. CARVYKTI is the first and only B-cell Maturation Antigen targeted therapy, including CAR-T therapies, bispecific antibodies, and antibody-drug conjugates, approved starting in the second-line of treatment for patients with multiple myeloma. “The expanded label of CARVYKTI has the potential to transform the treatment paradigm for multiple myeloma by providing patients and physicians with a personalized immunotherapy that can be used earlier in the treatment regimen. Multiple myeloma is an incurable and progressive hematologic cancer that causes patients to relapse and become refractory to treatment, so new, innovative options are desperately needed,” said Ying Huang, Chief Executive Officer of Legend Biotech. “We are committed to improving the lives of patients battling blood cancer and will continue to work towards developing cellular therapies that bring us closer to a cure.” The FDA approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone 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.1 Warnings and Precautions include Increased Early Mortality, Infections, Hypogammaglobulinemia, Hypersensitivity Reactions, and Effects on Ability to Drive and Use Machines.