Friday, the FDA approved Johnson & Johnson (NYSE:JNJ) Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy and are refractory to lenalidomide. FDA’s Oncologic Drugs Advisory Committee unanimously votes 11 to 0, supporting the favorable risk-benefit assessment of Carvykti based on results from the Phase 3 CARTITUDE-4 study. With this approval, Carvykti becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as the first relapse. FDA approval is based on 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% compared to standard therapies. “We understand the urgency for patients in need of Carvykti, and we have been making considerable progress in ...