Johnson & Johnson (J&J) has announced that Health Canada has granted a Notice of Compliance (NOC), a form of market approval, for Carvykti (ciltacabtagene autoleucel) in multiple myeloma treatment.
This approval allows Carvykti to treat adult multiple myeloma patients who have received one to three prior therapies, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
Carvykti is now the first and only B-cell Maturation Antigen (BCMA)-targeted therapy approved for multiple myeloma treatment as early as the second line.
In April, the therapy secured US Food and Drug Administration (FDA) approval to treat multiple myeloma patients who have received at least one prior line of therapy.
The drug previously received a Notice of Compliance with conditions (NOC/c) from Health Canada. It was approved for the treatment of adult multiple myeloma patients who have undergone at least three prior lines of therapy.
This latest Health Canada authorisation is based on results from the Phase 3 CARTITUDE-4 study.
This randomised, open-label, multicentre trial assessed the efficacy and safety of BCMA-targeted therapy versus standard of care treatments. A total of 419 patients were randomised to receive either Carvykti or standard of care.
After a median follow-up of 15.9 months, patients in the Carvykti arm showed a 74% reduction in the risk of disease progression or death compared to those receiving standard of care treatments.
Long-term results from the Phase 3 CARTITUDE-4 study demonstrated that a single infusion of Carvykti significantly extended overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy.
The data showed a 45% reduction in the risk of death compared to standard therapies.
Johnson & Johnson innovative medicine Canada president Berkeley Vincent said: “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.”
Ciltacabtagene autoleucel received an NOC/c from Health Canada in February 2023 for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapy.
In July 2024, the drug was further authorised by Health Canada for the treatment of adult multiple myeloma patients who have received one to three prior lines of therapy.
