Ciltacabtagene Autoleucel(Carvykti) Approval Date Order
Ciltacabtagene Autoleucel(Carvykti) Approval Date Order
The US Approval Time
In February 2022, the US FDA officially approved Ciltacabtagene Autoleucel (brand name: CARVYKTI®, abbreviation: Cilta-cel) for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM). This is the second BCMA CAR-T cell therapy approved by the FDA globally and the first domestically developed CAR-T cell therapy approved by the FDA.
The EU Approval Time
On May 27, 2022, the European Commission granted conditional marketing authorization for Ciltacabtagene Autoleucel for the treatment of adult patients with relapsed and refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
The Japan Approval Time
On September 27, 2022 (local time), Legend Biotech (NASDAQ: LEGN) officially announced in Somerset, New Jersey, USA, that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved CARVYKTI® (Ciltacabtagene Autoleucel, Cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM), limited to the following two conditions: patients with no prior exposure to B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy; patients who have received at least three lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and have either failed to respond or have relapsed after the last line of therapy.
The US Treatment Line Adjustment Time
On April 5, 2024, Legend Biotech/Johnson & Johnson jointly announced that the US FDA has approved Carvykti (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are lenalidomide-refractory.