Johnson & Johnson (J&J) and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) has been approved by the European Commission (EC) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least one prior therapy.
The approval marks Carvykti as the first B-cell maturation antigen chimeric antigen receptor t-cell therapy to be approved in Europe for this patient population as early as first relapse.
Responsible for more than 35,000 new cases in the EU in 2022, multiple myeloma is an incurable blood cancer, with most patients relapsing after standard treatment.
RRMM patients in the EU who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), who have demonstrated disease progression on the last therapy and are refractory to lenalidomide, will be eligible to receive Carvykti.
The EC also approved the conversion of the conditional marketing authorisation (MA) for Carvykti to a standard MA, as conditions of approval have now been met.
The EC’s decision was based on positive phase 3 results from the CARTITUDE-4 study, which evaluated the efficacy and safety of Carvykti in patients with relapsed and lenalidomide-refractory multiple myeloma.
Randomised to receive either a sequence of apheresis, bridging therapy, lymphodepletion and Carvykti or standard of care (SOC), results published in the New England Journal of Medicine showed that Carvykti demonstrated a significantly lower risk of disease progression or death versus SOC at a median follow up of 15.9 months, with an estimated 76% progression-free survival rate at 12 months compared to 49% with SOC.
In addition, patients who received Carvykti achieved an 85% overall response rate (ORR) and 73% achieved a complete response (CR) or better, compared to 67% ORR and 22% CR with SOC.
Jordan Schecter, vice president, disease area leader, multiple myeloma, J&J Innovative Medicine, commented: “[Carvytki] is an important part of how we are working to redefine multiple myeloma and ultimately achieve sustained remissions for patients.”
Initially approved in 2022 by the US Food and Drug Administration, the US regulator recently approved Carvykti in April for adult patients with RRMM who have received at least one prior line of therapy, including PI and IMiD, and who are refractory to lenalidomide.