Legend Biotech Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved a label update for CARVYKTI® (ciltacabtagene autoleucel, cilta-cel), its CAR-T cell therapy. The update allows inclusion of overall survival data from the Phase 3 CARTITUDE-4 study, which showed a statistically significant improvement in overall survival for CARVYKTI compared to standard of care in patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The updated label also adds new safety information, including warnings about immune effector cell-associated enterocolitis and progressive multifocal leukoencephalopathy linked to John Cunningham virus reactivation.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Legend Biotech Corporation published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001171843-25-006414), on October 14, 2025, and is solely responsible for the information contained therein.