22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies.
Janssen-Cilag announced today that the European Commission has approved a Type II variation for Carvykti (ciltacabtagene autoleucel).