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Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. Ciltacabtagene autoleucel is a BCMA (B-cell maturation antigen)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient.

The most common adverse reactions include pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting. Additional common side effects include neutropenia (low levels of neutrophils), lymphopenia and leucopenia (low levels of lymphocytes or other white blood cells), anemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets), hypotension (low blood pressure), pain of the muscles and bones, high level of liver enzymes, upper respiratory tract infection (nose and throat infection), diarrhea, hypokalemia (low level of potassium), hypocalcemia (low levels of calcium), hypophosphatemia (low levels of phosphate in the blood), nausea, headache, cough, tachycardia (rapid heartbeat), encephalopathy (a brain disorder), edema (fluid retention), decreased appetite, chills, fever, tiredness, as well as cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure).

Ciltacabtagene autoleucel was approved for medical use in the United States in February 2022, and in the European Union in May 2022.

Medical uses

Ciltacabtagene autoleucel is indicated for the treatment of adults with relapsed or refractory multiple myeloma after one or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

Adverse effects

In April 2024, the FDA label boxed warning was expanded to include T cell malignancies.

History

The safety and efficacy of ciltacabtagene autoleucel were evaluated in CARTITUDE-1 (NCT03548207), an open label, multicenter clinical trial evaluating ciltacabtagene autoleucel in 97 participants with relapsed or refractory multiple myeloma who received at least three prior lines of therapy which included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and who had disease progression on or after the last chemotherapy regimen; 82% had received four or more prior lines of antimyeloma therapy.

The U.S. Food and Drug Administration (FDA) granted the application for ciltacabtagene autoleucel priority review, breakthrough therapy, and orphan drug designations.

Society and culture

Legal status

In March 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Carvykti, intended for the treatment of adults with relapsed and refractory multiple myeloma. The applicant for this medicinal product is Janssen-Cilag International NV. Ciltacabtagene autoleucel was approved for medical use in the European Union in May 2022.

Names

Ciltacabtagene autoleucel is the international nonproprietary name.

References

1. "Cellular Therapies - T cells-Ciltacabtagene autoleucel, cryopreserved-T-Carvykti - Janssen-Cilag Pty Ltd - Injection, intravenous infusion - Bag (410143)". Therapeutic Goods Administration (TGA). 7 June 2023. Archived from the original on 19 April 2024. Retrieved 10 September 2023.
2. "Carvykti (Janssen-Cilag Pty Ltd)". Therapeutic Goods Administration (TGA). 23 June 2023. Archived from the original on 19 April 2024. Retrieved 10 September 2023.
3. "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 19 April 2024. Retrieved 11 September 2023.
4. "Details for: Carvykti". Health Canada. 9 February 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
5. "Notice: Multiple Additions to the Prescription Drug List (PDL) [2023-03-08]". Health Canada. 8 March 2023. Archived from the original on 22 March 2023. Retrieved 21 March 2023.
6. "Summary Basis of Decision for Carvykti". Drug and Health Products Portal. 1 September 2012. Archived from the original on 19 April 2024. Retrieved 18 June 2023.
7. "Carvykti Product information". Health Canada. 9 February 2023. Archived from the original on 19 April 2024. Retrieved 18 June 2023.
8. ^ "Carvykti- ciltacabtagene autoleucel injection, suspension". DailyMed. 9 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
9. ^ "Carvykti". U.S. Food and Drug Administration (FDA). 8 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022. This article incorporates text from this source, which is in the public domain.
10. ^ "Carvykti EPAR". European Medicines Agency. 22 March 2022. Archived from the original on 14 June 2022. Retrieved 13 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
11. ^ "Carvykti Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
12. ^ "FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 7 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022. This article incorporates text from this source, which is in the public domain.
13. Chekol Abebe E, Yibeltal Shiferaw M, Tadele Admasu F, Asmamaw Dejenie T (2022). "Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma". Frontiers in Immunology. 13: 991092. doi:10.3389/fimmu.2022.991092. PMC 9479060. PMID 36119032.
14. "U.S. FDA Approves Carvykti (ciltacabtagene autoleucel), Janssen's First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma". Janssen Pharmaceutical Companies (Press release). 1 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
15. "FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies". U.S. Food and Drug Administration (FDA). 18 April 2024. Archived from the original on 19 April 2024. Retrieved 19 April 2024. This article incorporates text from this source, which is in the public domain.
16. ^ "Carvykti: Pending EC decision". European Medicines Agency. 24 March 2022. Archived from the original on 25 March 2022. Retrieved 25 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
17. "New gene therapy to treat adult patients with multiple myeloma". European Medicines Agency (EMA) (Press release). 25 March 2022. Archived from the original on 25 March 2022. Retrieved 25 March 2022.
18. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.

• Medicine

• Antineoplastic drugs
• Approved gene therapies
• CAR T-cell therapy
• Orphan drugs