Conditional approval granted to cilta-cel by the EC

On May 26, 2022, the European Commission (EC) granted a conditional marketing authorization to ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed/refractory multiple myeloma (MM).¹ This decision is made 2 months after the favorable opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Cilta-cel’s approval is based on the results of the CARTITUDE-1 trial and depends on the provision of comprehensive and long-term data at a later stage. The current indication is for treating adult patients with relapsed/refractory MM who have received ≥3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.¹

Updated data from both the CARTITUDE-1 and CARTITUDE-2 trials are expected to be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA)2022 Hybrid Congress.^2,3

Review here the ongoing and planned clinical trials investigating cilta-cel for the treatment of patients with MM.