Carvykti EMA Approval for Second-Line Treatment of Multiple Myeloma
Carvykti EMA Approval for Second-Line Treatment of Multiple Myeloma
Carvykti Receives CHMP Recommendation for Approval for Front-Line Treatment of Multiple Myeloma
On February 23, 2024, Legend Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of an expanded indication for Carvykti (cilta-cel, Ciltacabtagene Autoleucel) to include adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy (including an immunomodulatory agent and a proteasome inhibitor) and have progressed on their last line of therapy and are refractory to lenalidomide. This Type II variation application was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of the collaboration partner Janssen, and the CHMP’s positive opinion will be reviewed by the European Commission for a final approval decision.
The CHMP’s recommendation for Carvykti is supported by data from the CARTITUDE-4 study. The study evaluated the efficacy and safety of Carvykti compared to Pomalidomide, Bortezomib, and Dexamethasone (PVd) or Daratumumab, Pomalidomide, and Dexamethasone (DPd) in patients with relapsed and lenalidomide-refractory multiple myeloma who had previously received 1-3 lines of therapy.
Previously released data from the Phase 3 CARTITUDE-4 clinical trial of Ciltacabtagene Autoleucel by Legend Biotech showed that, at a median follow-up of 16 months, Ciltacabtagene Autoleucel reduced the risk of disease progression or death by 74% in adult patients with relapsed and lenalidomide-refractory multiple myeloma who had received 1-3 prior lines of therapy, compared to standard-of-care (SOC) regimens. These results demonstrate that Ciltacabtagene Autoleucel has significant advantages in prolonging patient survival and delaying disease progression.
About CARTITUDE-4
CARTITUDE-4 (NCT04181827) is an international, randomized, open-label Phase 3 study evaluating the efficacy and safety of Ciltacabtagene Autoleucel compared to Pomalidomide, Bortezomib, and Dexamethasone (PVd) or Daratumumab, Pomalidomide, and Dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received 1-3 prior lines of therapy, with progression-free survival (PFS) as the primary endpoint.