NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) said that Health Canada has issued a Notice of Compliance for CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with multiple myeloma who have received one to three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide. With this approval, CARVYKTI becomes the first and only B-cell Maturation Antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as second line.
The authorization is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with CARVYKTI reduced the risk of disease progression or death by 74 per cent compared to standard of care.
CARVYKTI previously received a Notice of Compliance with conditions from Health Canada for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and who are refractory to their last treatment.
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