Johnson & Johnson Announces Health Canada Authorizes CARVYKTI For Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received 1-3 Prior Lines Of Therapy, Including A Proteasome Inhibitor And An Immunomodulatory Agent, And Who Are Refractory To Lenalidomide
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.1
TORONTO, Nov. 21, 2024 /CNW/ - Johnson & Johnson (NYSE:JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) 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.1 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.
CARVYKTI previously received a Notice of Compliance with conditions (NOC/c) 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.1
Canada's Drug Agency (CDA-AMC) has recently recommended CARVYKTI for reimbursement with conditions for eligible patients who have received one to three prior lines of therapy. In its rationale for the recommendation, CDA-AMC pointed out that the CARTITUDE-4 trial demonstrated that treatment with CARVYKTI, compared to standard of care, was associated with statistically significant and clinically meaningful improvements in progression-free survival (PFS) in eligible patients. This builds on their prior recommendation for reimbursement with conditions for CARVYKTI in 2023 in eligible patients who have received at least three prior lines of therapy, based on the results of the CARTITUDE-1 trial. Johnson & Johnson is actively working with the pan-Canadian Pharmaceutical Alliance to negotiate reimbursement for CARVYKTI to enable public access.
