Ciltacabtagene Autoleucel EMA is The First CAR-T Cell Therapy to Receive Positive Opinions
Ciltacabtagene Autoleucel EMA is The First CAR-T Cell Therapy to Receive Positive Opinions
On February 23, 2024, Legend Biotech announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of expanding the indication for CARVYKTI® (cilta-cel, Ciltacabtagene Autoleucel) to include 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 progressed on the last line of therapy and are refractory to lenalidomide.
CARVYKTI® (Ciltacabtagene Autoleucel) is a BCMA-directed, gene-modified autologous T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
With this approval, CARVYKTI becomes the first CAR-T therapy to receive a positive opinion from the EMA’s CHMP for the treatment of relapsed or refractory multiple myeloma in the second-line setting.
The CARTITUDE-4 study of CARVYKTI is an international, randomized, open-label Phase 3 study evaluating the efficacy and safety of Ciltacabtagene Autoleucel compared to Pomalidomide, Bortezomib, and Dexamethasone (PVd) or Daratumumab, Pomalidomide, and Dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who had received 1-3 prior lines of therapy, with progression-free survival (PFS) as the primary endpoint.
The results showed that patients with early relapse could obtain significant clinical benefit from this therapy. The CHMP’s positive opinion is an important step towards making CARVYKTI® available to more patients in Europe, allowing them to benefit from this one-time infusion therapy.
In December 2017, Legend Biotech signed a $350 million upfront payment collaboration agreement with Johnson & Johnson for Carvykti, jointly responsible for global drug development, clinical trials, manufacturing, and commercialization. In China, Legend Biotech owns 70%, and Johnson & Johnson owns 30%; in other regions, they share 50% each.
In February 2022, Carvykti received FDA approval for the treatment of relapsed or refractory multiple myeloma patients. According to Johnson & Johnson’s financial reports, Carvykti’s sales in 2022 were $134 million, and in 2023, sales reached $500 million, a 276% year-over-year increase. Sales are expected to exceed $1 billion in 2024.
On April 5, 2024, the FDA website showed that Carvykti received approval for a new indication for the treatment of relapsed or refractory multiple myeloma (R/RMM) patients.
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