On October 10, 2025, Legend Biotech Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a label update for CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) to include the overall survival (OS) analysis from the Phase 3 CARTITUDE-4 study showing a statistically significant improvement in OS for CARVYKTI compared to the standard of care therapy in patients with relapsed, refractory multiple myeloma after one to three prior lines of therapy. The label update is based on results from the prespecified second interim analysis of the CARTITUDE-4 study which demonstrated at a median follow-up of 33.6 months, neither CARVYKTI or standard of care therapy arms reached median OS in patients with one to three prior lines of therapy. In connection with the CARVYKTI label update to include updated OS data, immune effector cell-associated enterocolitis (IEC-EC) has been added to Boxed Warnings and Warnings and Precautions section of the label.
IEC-EC has occurred in patients treated with CARVYKTI with manifestations including severe or prolonged diarrhea, abdominal pain and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcomes from perforation or sepsis. FDA recommends that prescribing physicians manage adverse events of IEC-EC according to institutional guidelines and conduct additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the postmarketing setting.
Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML) was also added to Warnings and Precautions (under Infections) and Postmarketing Experience. PML has occurred in patients treated with CARVYKTI including cases with fatal outcomes. It is recommended that prescribing physicians perform appropriate diagnostic evaluations in patients with neurological adverse events.
