Posted by Michael Wonder on 01 Mar 2022
Carvykti (ciltacabtagene autoleucel), BCMA directed CAR-T therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma
28 February 2022 - Approval is primarily based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate of 98% in patients with refractory or relapsed multiple myeloma after four or more prior lines of therapy including proteasome inhibitor, immunomodulatory agent and anti-CD38 monoclonal antibody.
Legend Biotech today announced that the U.S. FDA has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel), for the treatment of adults with relapsed or refractory multiple myeloma who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
