Health Canada has issued a notice of compliance (NOC) for Johnson & Johnson's CARVYKTI (ciltacabtagene autoleucel), marking it as the first B-cell maturation antigen (BCMA)-targeted therapy available for multiple myeloma patients as early as the second line of treatment. This approval is specifically for adult patients who have previously undergone one to three lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
CARTITUDE-4 Trial Results
The NOC is based on the outcomes of the Phase III CARTITUDE-4 trial, an open-label, multicenter, and randomized study. The trial compared the efficacy and safety of CARVYKTI against standard-of-care regimens in patients with relapsed and lenalidomide-refractory multiple myeloma. Of the 419 patients involved, 208 were administered CARVYKTI, while 211 received standard treatments consisting of either pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).
The CARVYKTI arm demonstrated a significant 74% reduction in the risk of disease progression or death compared to standard care, with a median follow-up of 15.9 months. All patients in the CARVYKTI group received bridging therapy and underwent leukapheresis.
Reimbursement and Access
Canada’s Drug Agency recently recommended CARVYKTI for reimbursement with conditions for patients who have received one to three prior lines of therapy. This follows a similar recommendation based on the CARTITUDE-1 trial results from 2023, which focused on patients with at least three prior lines of therapy. Johnson & Johnson is currently in negotiations with the pan-Canadian Pharmaceutical Alliance to facilitate public access to CARVYKTI.
Company Statement
Berkeley Vincent, President of Johnson & Johnson Innovative Medicine Canada, stated, "This milestone underscores our commitment to discovering and developing best-in-class therapies, particularly for incurable forms of cancer where patients face difficult prognoses. CARVYKTI plays an important role in our work to redefine multiple myeloma and ultimately help patients achieve sustained remission. We are determined to get in front of cancer, and these recent regulatory and access milestones for CARVYKTI represent critical steps forward in reaching this goal."
