Legend Biotech Corporation (NASDAQ:LEGN) announced that the European Commission (EC) approved CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the second-line treatment of adult patients with relapsed and refractory multiple myeloma.
This innovative therapy is approved for use in patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and who have shown disease progression on the last therapy and are refractory to lenalidomide.
The EC's decision marks a significant step in making this novel one-time infusion therapy available to a broader spectrum of patients at an earlier stage in their treatment journey, potentially offering a treatment-free respite for those battling this incurable disease.
The approval is based on the positive results from the CARTITUDE-4 study, demonstrating that CARVYKTI® results in a statistically significant and clinically meaningful improvement of progression-free survival in comparison to standard care regimens.