The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed and lenalidomide-refractory multiple myeloma.
The application is supported by data from the Phase III CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel in the treatment of patients who received one to three prior lines of therapy.
CARTITUDE-4 was the first randomised Phase III study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma.
“The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited.
“Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.”
The CARTITUDE-4 study results will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday June 5, 2023.
Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The CAR-modified T cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T cells and enhance tumour-specific immunosurveillance.