Carvykti(Ciltacabtagene Autoleucel) Recommended for Approval by CHMP for Front-line Treatment of Multiple Myeloma
Carvykti(Ciltacabtagene Autoleucel) Recommended for Approval by CHMP for Front-line Treatment of Multiple Myeloma
On February 23, 2024, Legend Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval for the expanded indication of Carvykti (cilta-cel, ciltacabtagene autoleucel) to include the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor, and have demonstrated disease progression on the last line of therapy and refractory to lenalidomide. This Type II variation application was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of the partner Johnson & Johnson. The CHMP’s positive opinion will be reviewed by the European Commission for final approval decision.
Positive opinions on frontline treatment of Carvykti
The CHMP’s recommendation for Carvykti is supported by data from the CARTITUDE-4 study, which evaluated the efficacy and safety of Carvykti compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed and lenalidomide-refractory multiple myeloma after 1-3 prior lines of therapy. Ciltacabtagene autoleucel is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), which uses the patient’s own T cells modified with a chimeric antigen receptor (CAR) to recognize and eliminate BCMA-expressing cells. BCMA is primarily expressed on the surface of malignant multiple myeloma B-cell lineage cells, late-stage B cells, and plasma cells. The CAR protein of ciltacabtagene autoleucel contains two single-domain antibodies targeting BCMA with high affinity, and upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and subsequent elimination of the target cells.
In December 2017, Janssen entered into a worldwide exclusive license and collaboration agreement with Legend Biotech to develop and commercialize ciltacabtagene autoleucel. In February 2022, ciltacabtagene autoleucel received FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma. Multiple myeloma (MM) is considered an incurable blood cancer caused by the excessive proliferation of plasma cells in the bone marrow. It is estimated that in 2024, over 35,000 people in the United States will be diagnosed with multiple myeloma, and more than 12,000 will die from the disease. While some multiple myeloma patients are asymptomatic and diagnosed due to the appearance of symptoms, these symptoms may include bone lesions, abnormal blood cell counts, hypercalcemia, kidney problems, or infections.
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