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Tuesday 1st of March 2022 02:25:50 AM

J&J, Legend Biotech's Carvykti for multiple myeloma gets US FDA approval

Headquarters of US Food and Drug Administration (FDA) Grandbrothers/iStock Editorial via Getty Images The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson (NYSE:JNJ) and Legend Biotech's (NASDAQ:LEGN) CAR-T therapy Carvykti to treat adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The approval of Carvykti (ciltacabtagene autoleucel; cilta-cel) is based on positive data from the CARTITUDE-1 study. Carvykti marks the first product approved by the FDA for Legend. In December 2017, J&J's Janssen signed an exclusive worldwide license and collaboration agreement with Legend to develop and commercialize ciltacabtagene autoleucel. “Today’s approval of CARVYKTI is a pivotal moment for Legend Biotech because it is our first-ever marketing approval, but what really excites us is the drug’s potential to become an impactful therapy option for patients in need of long, treatment-free intervals," said Legend CEO and CFO Ying Huang. The companies said Carvykti is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI REMS Program. Carvykti includes a Boxed Warning regarding Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, Parkinsonism and Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), and prolonged and/or recurrent cytopenias. Multiple myeloma is a cancer that forms in a type of white blood cell known as plasma cell. LEGN +7.48% premarket to $42.55
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