Johnson & Johnson announced 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. 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.
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."
"The clinical trial showed that a single infusion of CARVYKTI® significantly lowered the risk of disease progression or death compared to current standard of care," says Dr. Richard LeBlanc, Hematologist, Maisonneuve-Rosemont Hospital. "This authorization means patients have a more effective treatment option that offers an opportunity for a deeper and durable response as early as their first relapse."
Multiple myeloma is the second most common form of blood cancer in Canada and it is estimated that 1,750 Canadians will die from the disease in 2024. While the introduction of novel therapies in recent years has led to significant improvements in PFS and overall survival (OS) in patients with multiple myeloma, the disease remains incurable, with nearly all patients relapsing and requiring subsequent therapy. As the disease progresses, patients experience cycles of relapse and remission, with periods of remission generally becoming progressively shorter with each new line of therapy.
"With the progressive, cyclical nature of multiple myeloma, the sooner we can give patients the treatment that is right for them, the higher the likelihood that more patients achieve better outcomes and an improved quality of life," says Martine Elias, CEO, Myeloma Canada. "This approval offers patients hope that their next treatment will help extend remission and give them more precious quality time with their loved ones."
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