Carvykti FDA Approval History
Last updated by Judith Stewart, BPharm on April 8, 2024.
FDA Approved: Yes (First approved February 28, 2022)
Brand name: Carvykti
Generic name: ciltacabtagene autoleucel
Dosage form: Suspension for Intravenous Infusion
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Carvykti (ciltacabtagene autoleucel) is a BCMA-directed CAR-T immunotherapy for the treatment of patients with relapsed or refractory multiple myeloma.
- Carvykti is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
- Carvykti is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy. A patient's white blood cells are harvested via leukapheresis and processed into Carvykti at a specialized manufacturing center.
- Carvykti is administered as a single dose intravenous infusion over a period of 30-60 minutes. A lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine is administered for three days prior to receiving the infusion. Acetaminophen and an antihistamine are administered as premedication 30 to 60 minutes prior to receiving the infusion.
- The approval for Carvykti was based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens. One-time treatment with ciltacabtagene autoleucel resulted in deep and durable responses, with 98 percent of patients responding to therapy and 78 percent of patients experiencing a stringent complete response (sCR). The median duration of response (DOR) was 21.8 months.
- Carvykti is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Carvykti REMS. Carvykti can only be administered at a REMS-certified healthcare facility.
- The Carvykti product label carries a boxed warning for Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), prolonged and/or recurrent cytopenias, and secondary hematological malignancies.
- Common adverse reactions include pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.
Common laboratory adverse reactions include lymphopenia, neutropenia, decreased white blood cell count, thrombocytopenia, and anemia.
Development timeline for Carvykti
Further information
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