Health Canada has issued a notice of compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI (ciltacabtagene autoleucel), making it the first B-cell maturation antigen-targeted therapy for multiple myeloma patients as early as the second line of treatment.
This is specifically indicated for adult individuals who have received one to three previous therapies, along with a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
The NOC is based on the open-label, multicentre and randomised Phase III CARTITUDE-4 trial outcomes.
The study compared CARVYKTI's efficacy and safety against standard-of-care regimens in patients with relapsed and lenalidomide-refractory multiple myeloma.
Of 419 patients participating, 208 received CARVYKTI and 211 received standard treatments which consisted of either pomalidomide, bortezomib and dexamethasone (PVd), or daratumumab, pomalidomide and dexamethasone (DPd).
All patients in the CARVYKTI group received bridging therapy and have undergone leukapheresis [a process to remove extra white blood cells from blood].
The CARVYKTI arm showed a 74% reduction in the disease progression or death risk when compared to standard care at a median of 15.9 months.
Canada's Drug Agency recently recommended the therapy for reimbursement with conditions for patients who have received one to three previous lines of therapy.
This follows a similar recommendation for patients with at least three prior lines of therapy, based on 2023's CARTITUDE-1 trial results.
The company is currently negotiating with the pan-Canadian Pharmaceutical Alliance to facilitate public access to CARVYKTI.
Johnson & Johnson innovative medicine Canada president Berkeley Vincent 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."
In November 2024, the US Food and Drug Administration awarded the second breakthrough status to J&J’s nipocalimab for treating individuals with moderate-to-severe Sjögren’s disease.
