FDA approval for Carvykti, a CAR-T therapy from Legend Biotech

1 March 2022

Legend Biotech (Nasdaq: LEGN), a clinical stage CAR-T immuno-oncology biotech spun out of Hong Kong-listed GenScript Biotech, says that the US Food and Drug Administration has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel), for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Legend Biotech, whose shares edged up around 3% to $39.59 in the news, entered into an exclusive worldwide license and collaboration agreement with US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Biotech, to develop and commercialize cilta-cel in December 2017.

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