Johnson & Johnson (JNJ) has announced that Health Canada has granted a Notice of Compliance for CARVYKTI (ciltacabtagene autoleucel). This treatment is intended for adult patients with multiple myeloma who have undergone between one and three previous lines of therapy, which must include a proteasome inhibitor and an immunomodulatory agent, and are resistant to lenalidomide. With this approval, CARVYKTI stands out as the first and sole therapy targeting the B-cell Maturation Antigen (BCMA) to be sanctioned for use in multiple myeloma patients as early as the second line of treatment.
The endorsement comes on the heels of findings from the Phase 3 CARTITUDE-4 (MMY3002) study, where CARVYKTI demonstrated a 74 percent reduction in the risk of disease progression or death compared to traditional standard care.
Previously, CARVYKTI received a Notice of Compliance with conditions from Health Canada for treating adult patients with multiple myeloma who had experienced at least three preceding lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and who were resistant to their most recent treatment.