J&J, Legend’s Phase III Win Cements Carvykti as Earlier-Line Multiple Myeloma Treatment

1. FDA Approval: Carvykti, a BCMA-targeted cell therapy, has been approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
2. Phase III CARTITUDE-4 Study: The approval is based on the results of the Phase 3 CARTITUDE-4 study, which demonstrated that Carvykti reduced the risk of disease progression or death by 59% compared to standard therapies.
3. Earlier-Line Treatment: Carvykti is now the first and only BCMA-targeted therapy approved for the treatment of multiple myeloma as early as first relapse, providing more patients with a potential period away from their multiple myeloma treatment.
4. Manufacturing Advances: Johnson & Johnson has made significant advances in manufacturing to rapidly scale Carvykti production, aiming to double production in 2024 and continue investing in capacity to provide the critical therapy to as many patients as possible.
5. Market Position: Carvykti has become the market leader in the late-line multiple myeloma treatment, holding about 80% of the market share among U.S. treatment centers that offer both Carvykti and Abecma.
6. Future Trials: The CARTITUDE-5 trial is testing Carvykti in patients with newly diagnosed multiple myeloma not intended for stem cell transplant, and the CARTITUDE-6 study is trying to replace transplants with Carvykti in transplant-eligible patients.