The European Commission has approved marketing authorisation extension for the CAR-T treatment ciltacabtagene autoleucel (Carvytki®), also known as cilta-cel, for use in patients who have received at least one prior therapy, including an immunomodulatory agent (IMiD – such as lenalidomide and pomalidomide) and a proteasome inhibitor (PI – such as bortezomib or carfilzomib), have demonstrated disease progression on the last therapy and are refractory (i.e. no longer responding) to lenalidomide.

This follows an earlier positive recommendation from the EMA – Committee for Medicinal Product for Human Use (CHMP), after which the European Commission had 60 days to ratify.

The Commission´s decision is based on the results of the Phase III clinical trial data from CARTITUDE-4 which looked at cilta-cel in patients who had one to three prior lines of therapy and were no longer responding to lenalidomide (i.e. lenalidomide refractory). The trial compared cilta-cel to a physician’s choice of either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) until disease progression. Patients in the cilta-cel arm also received PVd and DPd bridging therapy, prior to their single infusion of cilta-cel.

Cilta-cel was initially approved by the European Commission for myeloma patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti‑CD38 antibody and whose disease has worsened since the last treatment. The new European Commission approval means that cilta-cel will be licenced for use in earlier stages of myeloma (after at least one prior treatment). However, for patients to receive the treatment it usually requires a funding decision of national health authorities. MPE will continue to engage with members, industry and other stakeholders to understand access to cilta-cel in Europe.

MPE interviewed Dr. Hermann Einsele, Director of the Department of Internal Medicine II at the Würzburg University Hospital, Germany, at the European Hematology Association annual congress 2023 about the CARTITUDE-4 study. You can watch the video interview here.

For further information on cilta-cel, you can read the MPE ciltacabtagene autoleucel factsheet here.