Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel in the treatment of patients who received one to three prior lines of therapy.
Janssen today announced the submission of a Type II variation application to the EMA seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.
