28 September 2022 - Legend Biotech announced today that Japan’s MHLW has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA) directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting two conditions. 

The conditions are:

• Patients have no history of CAR positive T cell infusion therapy targeting BCMA
• Patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy

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