Janssen’s Carvykti (ciltacabtagene autoleucel) has been recommended by the European Medicines Agency’s human medicines committee to treat earlier lines of relapsed and refractory multiple myeloma (RRMM).
The recommendation makes Carvykti the first chimeric antigen receptor T-cell (CAR-T) therapy to receive a positive opinion for the treatment of RRMM patients as early as after the first relapse.
Affecting around 160,000 people worldwide, multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow.
For most patients, relapse after current standard treatments is common and remains in need of additional therapeutic options at earlier stages of the disease.
Working directly against B-cell maturation antigen, a protein expressed on myeloma cells, Carvykti reprogrammes patients’ own T-cells with a transgene encoding a CAR that eliminates BCMA-expressing cells.
The Committee for Medicinal Products for Human Use (CHMP) has recommended Carvykti in adult RRMM patients who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
The recommendation was based on positive data from the phase 3 CARTITUDE-4 study, a randomised trial evaluating the efficacy and safety profile of Carvykti versus pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone in patients with relapsed and lenalidomide-refractory multiple myeloma who receive one to three prior lines of therapy.
“[The] recommendation… recognises the potential of [Carvykti] to significantly improve outcomes for eligible patients with RRMM, as early as after first relapse,” said Edmond Chan, senior director, EMEA therapeutic area lead haematology, Janssen UK, a Johnson & Johnson Company.
Sen Zhuang, vice president, clinical research and development, Johnson & Johnson Innovative Medicine, commented: “[The] milestone represents an important step forward in the treatment of this complex disease and in our ultimate goal of one day delivering a cure.”
In May 2022, Janssen’s Carvykti received approval under conditional marketing authorisation (CMA) to treat adults with RRMM after three prior lines of therapy.
Most recently, the CHMP recommended converting the CMA for Carvykti to a standard marketing authorisation after meeting the obligations of the conditional approval.