Johnson & Johnson (J&J) and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) has been approved by the US Food and Drug Administration (FDA) as a second-line treatment for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The approval marks the B-cell maturation antigen (BCMA)-targeted therapy as the first and only to be approved in the US for this patient population as early as the first relapse.
Estimated to be responsible for more than 35,000 cases in the US this year, multiple myeloma is an incurable blood cancer that rapidly spreads and replaces normal cells in the bone marrow with tumours.
The FDA’s approval was based on positive results from the phase 3 CARTITUDE-4 study, which evaluated the efficacy and safety of Carvykti versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in 419 adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.
The cell therapy works by harnessing a patient’s immune system, or T-cells, to tackle the disease and was initially approved in 2022 by the FDA.
Published in the New England Journal of Medicine and presented at the 2023 American Society of Clinical Oncology, results demonstrated that the earlier use of Carvykti reduced the risk of disease progression or death by 59% compared to PVd or DPd.
In addition, the study also reported key secondary results, including overall response and overall survival.
The new indication will allow more multiple myeloma patients to be able to access this treatment “as early as the first relapse, with the hope of eliminating the burden of having to be on continuous treatment while living with this challenging disease,” said Binod Dhakal, associate professor, Medical College of Wisconsin, division of haematology and oncology.
Jordan Schecter, vice president, disease area leader, multiple myeloma, J&J Innovative Medicine, commented: “We are proud to bring an important, highly effective immunotherapy… to physicians and patients for the earlier treatment of relapsed/refractory multiple myeloma and we look forward to building on this latest milestone as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma.”