EMA approva CARVYKTI in seconda linea nel trattamento del mieloma multiplo
The European Commission’s approval of J&J’s CARVYKTI® for R/R Multiple Myeloma was based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74% compared to standard therapies.
The Type II variation for CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) is for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA), a protein highly expressed on myeloma cells.
More than 35,000 new cases of multiple myeloma were diagnosed in the European Union in 2022. Most patients with multiple myeloma relapse after standard treatment. Each additional line of therapy is associated with lower response rates, shorter treatment-free intervals, and increased rates of toxicities and comorbidities.