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Ciltacabtagene autoleucel, is FDA approved for multiple myeloma. It is for adults with relapsed or refractory multiple myeloma not separately approved for plasmocytoma in specific treatment settings. Patients must have had four or more prior therapies. These include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
On April 5, 2024, the FDA expanded the indication. It now includes adults with relapsed or refractory multiple myeloma after at least one prior therapy. This must include a proteasome inhibitor and an immunomodulatory agent. Patients must also be refractory to lenalidomide (2)
In March 2022, the [EMA](brain://QMGe2vnxWkWiArAahJp9aA…