Approval of cilta-cel by the FDA and its impact on the treatment landscape

Maximilian Merz, MD, Leipzig University, Leipzig, Germany, Roswell Park Comprehensive Center Institute, Buffalo, NY, comments on the recent approval of ciltacabtagene autoleucel (cilta-cel) by the FDA and foresees it will be of great benefit for patients with multiple myeloma. Previously approved chimeric antigen receptor (CAR-T) therapies in the US and the EU such as idecabtagene vicleucel (ide-cel) have experienced availability issues, which will be compensated by the approval of cilta-cel in Europe in 2022. Follow-up of the CARTITUDE-1 (NCT03548207) study results shows that 70% of responders to cilta-cel have no disease progression after two years, with high overall response rates (ORRs) and measurable residual disease (MRD)-negativity, making this CAR-T therapy a landscape changer once it becomes available in the European Union. This interview took place at the 48th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) 2022, which was held virtually.