According to an April 22 press release from Johnson & Johnson, the European Commission (EC) has approved CARVYKTI (ciltacabtagene autoleucel; cilta cel) as the “first BCMA-targeted treatment for relapsed and refractory multiple myeloma (RRMM) patients who have received at least one prior line of therapy.”

The approval 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 percent compared to standard therapies.”

Data from the study were previously published in The New England Journal of Medicine (San-Miguel J, et al. Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. N Engl J Med 2023;389(4):335-347.)

Carvykti has been approved for the treatment of RRMM patients “who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.”

"Cilta-cel is an innovative chimeric antigen receptor T-cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA), a protein that is highly expressed on myeloma cells. With this approval, cilta-cel becomes the first BCMA CAR-T therapy approved in Europe for the treatment of eligible patients as early as first relapse.”

The press release further notes that “expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse.”

To learn more, read the Johnson & Johnson press release from the button below.



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