The recommendation for granting Type II variation approval supports the use of cilta-cel for adult patients with RRMM who have received a minimum of one therapy earlier, including an immunomodulatory agent and a proteasome inhibitor, and are refractory to lenalidomide.
A chimeric antigen receptor T-cell (CAR-T) therapy, cilta-cel acts on B-cell maturation antigen (BCMA), a protein prevalent on myeloma cells.
This marks the first time a CAR-T therapy has received a positive CHMP opinion for this patient group, potentially after just one relapse.
The CHMP’s positive stance is based on data from the CARTITUDE-4 study, a randomised Phase III clinical trial designed to compare cilta-cel’s efficacy and safety to standard treatments.
The standard therapies comprised treatment with pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
Currently, cilta-cel holds a conditional marketing authorisation (CMA) for treating RRMM after three prior therapies in adult patients.
As per the latest development, the CHMP recommended upgrading this CMA to a standard marketing authorisation, as the conditions for the initial approval have been fulfilled.
In May 2022, the European Commission granted approval for cilta-cel for use in adults with RRMM who had undergone at least three previous therapies and showed disease progression on their last treatment.
Cilta-cel therapy involves reprogramming the T-cells of a patient to act on and remove BCMA-expressing cells.
Janssen signed a worldwide licence and partnership agreement with Legend Biotech for the development and marketing of cilta-cel, in December 2017.
Janssen-Cilag EMEA Therapeutic Area Lead Haematology senior director Edmond Chan said: “Early resistance to standard treatments is becoming more common in patients with lenalidomide-refractory multiple myeloma, highlighting a need for new options earlier in the course of treatment.
“The recommendation from the CHMP recognises the potential of cilta-cel to significantly improve outcomes for eligible patients with relapsed and refractory multiple myeloma, as early as after first relapse.”