The Janssen subsidiary of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an additional indication application to the US Food and Drug Administration (FDA) for its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel). The application seeks approval for the treatment of relapsed or refractory multiple myeloma (r/rMM) in adults who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
Phase III Study Data Supports Filing
The filing is supported by positive results from a Phase III study where Carvykti met the primary endpoint of significantly improving progression-free survival (PFS), leading to the unblinding of the trial. Additionally, the therapy demonstrated success in achieving a number of secondary endpoints, further validating its potential efficacy in treating r/rMM.
European Medicines Agency (EMA) Reviewing Similar Filing
According to Fineline Info & Tech data, the European Medicines Agency (EMA) is currently reviewing a similar filing from Janssen for Carvykti. This indicates that Janssen is actively pursuing regulatory approvals for its CAR-T cell therapy in multiple regions, reflecting the global demand for innovative treatments for multiple myeloma.-Fineline Info & Tech
