Cilta-Cel Approved for Expanded Use in Patients with Relapsed or Refractory Multiple Myeloma

The US Food and Drug Administration (FDA) has approved ciltacabtagene autoleucel (cilta-cel; CARVYKTI™) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

The approval was based on positive results from the phase III CARTITUDE-4 study, which demonstrated that the earlier use of cilta-cel reduced the risk of disease progression or death by 59% compared with standard therapies in adults with relapsed and lenalidomide-refractory MM who received one to three prior lines of therapy.

Cilta-cel was previously approved by the FDA for the treatment of patients with relapsed or refractory MM after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This approval was supported by the earlier CARTITUDE-1 study.