In 2022, Janssen Carvykti Has Been Approved To Be Listed In The United States, Japan and Europe Respectively
In 2022, Janssen Carvykti Has Been Approved To Be Listed In The United States, Japan and Europe Respectively
On February 28, 2022 (Horsham, Pennsylvania), Carvykti (cilta-cel) or Ciltacabtagene Autoleucel, a BCMA CAR-T product developed by Janssen, a subsidiary of Johnson & Johnson, and Legend Biotech, received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM).
Carvykti is the second FDA-approved CAR-T therapy targeting BCMA.
The approval was based on data from the pivotal CARTITUDE-1 study, an open-label, multicenter, phase 1b/2 study in adults with relapsed or refractory multiple myeloma who had received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
According to the latest data presented at the 63rd American Society of Hematology (ASH) Annual Meeting in 2021, with a median follow-up of nearly two years in 97 patients with relapsed or refractory multiple myeloma, the overall response rate was 98%, the stringent complete response rate was 83%, and the 2-year progression-free survival and overall survival rates were 61% and 74%, respectively. The median time to first response was 1 month, the median time to best response was 2.6 months, and the median time to complete response or better was 2.9 months.
In terms of safety, the long-term follow-up data did not reveal any new safety signals, and the safety profile of Ciltacabtagene Autoleucel was consistent across subgroups with the overall population. In the previous 18-month follow-up data, the most common hematologic adverse events (AEs) observed were neutropenia, anemia, thrombocytopenia, leukopenia, and lymphopenia.
Previously, Ciltacabtagene Autoleucel had received Orphan Drug Designation, Breakthrough Therapy Designation, and Priority Review Designation from the FDA, and has been included as a breakthrough therapeutic product in China. In December 2017, Janssen entered into a worldwide exclusive license and collaboration agreement with Legend Biotech USA, Inc. (Legend Biotech) to develop and commercialize Ciltacabtagene Autoleucel.
Carvykti (Ciltacabtagene Autoleucel, cilta-cel), also known as JNJ-4528/LCAR-B38M, is a differentiated chimeric antigen receptor T-cell (CAR-T) therapy containing a 4-1BB costimulatory domain and two antibody domains targeting B-cell maturation antigen (BCMA), a protein highly expressed on multiple myeloma cells, making it an ideal target for the treatment of multiple myeloma.
On May 26 and September 26 of the same year, Carvykti also received approval in Europe and Japan, respectively, for the treatment of adult patients with relapsed or refractory multiple myeloma.