Health Canada Authorizes CARVYKTI® (ciltacabtagene autoleucel) for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy

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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.

Johnson & Johnson Logo (CNW Group/Janssen Inc.)
Johnson & Johnson Logo (CNW Group/Janssen Inc.)

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.

"The new approval for CARVYKTI® fills an important gap for patients with multiple myeloma who may require this therapy as early as first relapse and represents a significant milestone for Canadian patients with this disease," says Dr. Donna Reece*, MD, Chief Medical Officer, Canadian Myeloma Research Group. "The first approval for CARVYKTI® was for its use in treating patients with refractory myeloma who had received at least three prior lines of therapy that included the three main drug classes (proteasome inhibitors, immunomodulatory drugs and anti-CD38 monoclonal antibodies). However, myeloma treatment options have advanced rapidly, and Canadian patients with relapsed multiple myeloma may have received all these agents in second- or even first-line treatment, and yet have not qualified for CARVYKTI® — a highly effective immunotherapy that is transforming the treatment of multiple myeloma. This expanded indication will allow eligible patients with multiple myeloma to receive CARVYKTI® much earlier in their treatment journey."