Carvykti Indication for Relapsed or Refractory Multiple Myeloma in Adult Patients

Carvykti Indication for Relapsed or Refractory Multiple Myeloma in Adult Patients

Carvykti Indication

Carvykti (ciltacabtagene autoleucel, cilta-cel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy 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.

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. In multiple myeloma, these plasma cells become abnormal, multiply uncontrollably, and replace normal cells in the bone marrow. Some patients diagnosed with multiple myeloma initially have no symptoms, but most patients are diagnosed with symptoms that may include bone fractures or pain, low red blood cell counts, fatigue, high calcium levels, kidney problems, or infections.

Ciltacabtagene autoleucel (cilta-cel; Carvykti) demonstrated significant improvement in progression-free survival (PFS) in patients with relapsed/lenalidomide (Revlimid) refractory multiple myeloma who had received 1 to 3 prior lines of therapy, meeting the primary endpoint of the Phase 3 CARTITUDE-4 trial (NCT04181827).

Overview of Carvykti’s Approval for Market Launch

Carvykti received approval from the U.S. Food and Drug Administration (FDA) in February 2022 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.

In May 2022, the European Commission granted conditional marketing authorization for Carvykti (cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma 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.

In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI for the treatment of patients with relapsed or refractory multiple myeloma who have no history of anti-BCMA CAR-positive T-cell infusion therapy and have received three or more prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody), and whose multiple myeloma has not responded to or has relapsed after the most recent therapy.

Mechanism of Action of Carvykti

Carvykti is a BCMA-directed, genetically modified autologous T-cell immunotherapy that involves reprogramming the patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that can guide the CAR-positive T cells to eliminate cells expressing BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B cells and late-stage B cells and plasma cells. The Carvykti CAR protein has two BCMA-targeting single-domain antibodies designed to confer high avidity to human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, proliferation, and elimination of the target cells.

Content Source:海德康