FDA approves earlier use of Carvykti CAR-T for multiple myeloma

The FDA has approved ciltacabtagene autoleucel, also known as cilta-cel, for earlier use in certain adults with relapsed or refractory multiple myeloma. This CAR T-cell therapy can now be used after the first relapse in adults who are refractory to lenalidomide and have received previous lines of therapy. Cilta-cel has shown efficacy in reducing disease progression or death by 59% compared to standard therapy in a phase 3 trial. Common adverse events include cytokine release syndrome and hypogammaglobulinemia. The therapy comes with boxed warnings for various side effects. Overall, this approval marks a milestone in improving outcomes for patients with multiple myeloma.

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