
The European Commission has approved Cilta-cel for the treatment of relapsed or refractory multiple myeloma (MM), according to a press release from Legend Biotech Corporation.
Cilta-cel is now indicated for adult patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent; are refractory to lenalidomide; and have experienced disease progression on their most recent therapy.
The approval of cilta-cel was supported by positive findings in the CARTITUDE-4 study, in which cilta-cel exhibited statistically significant and clinically meaningful improvements in progression-free survival compared with PVd or DPd in adults with relapsed and lenalidomide-refractory MM with one to three prior lines of therapy.
Cilta-cel was also recently approved by the FDA for adult patients with relapsed or refractory MM with at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, who are refractory to lenalidomide.