Posted by Michael Wonder on 27 May 2022
Carvykti (ciltacabtagene autoleucel) granted conditional approval by the European Commission for the treatment of patients with relapsed and refractory multiple myeloma
26 May 2022 - The approval is based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate of 98% in patients with relapsed or refractory multiple myeloma following a one-time treatment with ciltacabtagene autoleucel.
Legend Biotech today announced that the European Commission has granted conditional marketing authorisation of Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
