The United States, Europe, and Japan Have Already Used Carvykti Approval For The Treatment Of ,Multiple Myeloma
The United States, Europe, and Japan Have Already Used Carvykti Approval For The Treatment Of ,Multiple Myeloma
Carvykti Approval and Marketing Status
Carvykti was approved in the US on February 28, 2022
On February 28, 2022, Legend Biotech (NASDAQ: LEGN) officially announced in Somerset, New Jersey, USA, that its independently developed cell therapy product Ciltacabtagene Autoleucel (commercial name: Carvykti®, abbreviated as Cilta-cel) was approved for marketing by the US FDA for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Legend Biotech and Janssen entered into a worldwide exclusive license and collaboration agreement in December 2017 to develop and commercialize Carvykti®.
Legend Biotech’s Ciltacabtagene Autoleucel Carvykti® received FDA approval for the treatment of adults with relapsed/refractory multiple myeloma (MM), becoming the first cell therapy product from China to receive FDA approval and the second FDA-approved CAR-T cell immunotherapy targeting BCMA globally.
Carvykti was approved in the EU on May 26, 2022
On May 26, 2022, Legend Biotech (NASDAQ: LEGN) officially announced in Somerset, New Jersey, USA, that the European Commission (EC) has granted conditional marketing authorization for Carvykti® (Ciltacabtagene Autoleucel, abbreviated as Cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
Carvykti was approved in Japan on September 27, 2022
On September 27, 2022, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved Carvykti (Ciltacabtagene Autoleucel), a chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who meet the following conditions:
Have received prior BCMA-directed CAR-positive T-cell infusion therapy; and have received at least three prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and did not achieve a response or relapsed after the last treatment.
About Multiple Myeloma (MM)
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow, characterized by excessive proliferation of plasma cells. While some multiple myeloma patients may be asymptomatic, most patients are diagnosed due to symptoms including bone problems, low blood cell counts, high calcium levels, kidney problems, or infections. Although treatment may lead to remission, patients are likely to relapse. Patients who relapse after standard therapies (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies) have a poor prognosis and very limited treatment options available.
About Carvykti® (Cilta-cel, Ciltacabtagene Autoleucel)
Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA), in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) to recognize and eliminate BCMA-expressing cells. BCMA is primarily expressed on the surface of malignant multiple myeloma B cells, late-stage B cells, and plasma cells. Carvykti®’s CAR protein contains two BCMA-targeting single-domain antibodies, exhibiting high affinity to BCMA-expressing cells. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, proliferation, and subsequent elimination of the target cells.
Carvykti
Carvykti is a BCMA-targeted CAR-T therapy that genetically modifies a patient’s own T cells to express a chimeric antigen receptor (CAR) to recognize and eliminate BCMA-expressing cells. These approvals represent a significant step forward in the progression of multiple myeloma disease, bringing new hope for more patients with this condition.