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Carvykti FDA Approval History

Last updated by Judith Stewart, BPharm on March 9, 2022.

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 (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
  • 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, neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) and recurrent cytopenias.
  • Common non-laboratory adverse reactions include pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, 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 thrombocytopenia, neutropenia, anemia, aminotransferase elevation and hypoalbuminemia.

Development timeline for Carvykti

DateArticle
Feb 28, 2022Approval FDA Approves Carvykti (ciltacabtagene autoleucel) BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Dec 12, 2021New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
Nov  1, 2021Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel
Dec 21, 2020Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma

Further information

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