Ciltacabtagene autoleucel explained

Tradename:Carvykti
Dailymedid:Ciltacabtagene_autoleucel
Pregnancy Au:C
Pregnancy Au Comment:[1]
Routes Of Administration:Intravenous
Class:Antineoplastic
Atc Prefix:L01
Atc Suffix:XL05
Legal Au Comment:C4 (class 4 biological)[2] [3]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[4] [5] [6] [7]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Eu Comment:[8]
Drugbank:DB16738
Unii:0L1F17908Q
Kegg:D12315
Synonyms:JNJ-68284528

Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma.[9] [10] [11] 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,[12] [13] and in the European Union in May 2022.

Medical uses

In the US, 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.[14]

In the EU it is indicated for the treatment of adults 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.

Adverse effects

In April 2024, the FDA label boxed warning was expanded to include T cell malignancies.[15]

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

On 24 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.[16] The applicant for this medicinal product is Janssen-Cilag International NV.[17] Ciltacabtagene autoleucel was approved for medical use in the European Union in May 2022.[18]

Names

Ciltacabtagene autoleucel is the international nonproprietary name.[19]

Notes and References

  1. Web site: 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 . 10 September 2023 . 19 April 2024 . https://web.archive.org/web/20240419004927/https://www.tga.gov.au/resources/artg/410143 . live .
  2. Web site: Carvykti (Janssen-Cilag Pty Ltd) . Therapeutic Goods Administration (TGA) . 23 June 2023 . 10 September 2023 . 19 April 2024 . https://web.archive.org/web/20240419004926/https://www.tga.gov.au/resources/prescription-medicines-registrations/carvykti-janssen-cilag-pty-ltd . live .
  3. Web site: TGA eBS - Product and Consumer Medicine Information Licence . 11 September 2023 . 19 April 2024 . https://web.archive.org/web/20240419004722/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-01764-1 . live .
  4. Web site: Details for: Carvykti . . 9 February 2023 . 3 March 2024 . 3 March 2024 . https://web.archive.org/web/20240303051743/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102410 . live .
  5. Web site: Notice: Multiple Additions to the Prescription Drug List (PDL) [2023-03-08] ]. . 8 March 2023 . 21 March 2023 . 22 March 2023 . https://web.archive.org/web/20230322024545/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/mutliple-additions-2023-03-08.html . live .
  6. Web site: Summary Basis of Decision for Carvykti . Drug and Health Products Portal . 1 September 2012 . 18 June 2023 . 19 April 2024 . https://web.archive.org/web/20240419004754/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684955300002 . live .
  7. Web site: Carvykti Product information . . 9 February 2023 . 18 June 2023 . 19 April 2024 . https://web.archive.org/web/20240419004813/https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102410 . live .
  8. Web site: Carvykti EPAR . European Medicines Agency . 22 March 2022 . 13 June 2022 . 14 June 2022 . https://web.archive.org/web/20220614032120/https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. Web site: 9 March 2022 . Carvykti- ciltacabtagene autoleucel injection, suspension . live . https://web.archive.org/web/20220317045930/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2 . 17 March 2022 . 16 March 2022 . DailyMed.
  10. Web site: FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma . U.S. Food and Drug Administration (FDA) . 7 March 2022 . 16 March 2022 . 17 March 2022 . https://web.archive.org/web/20220317045650/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma . live .
  11. Chekol Abebe E, Yibeltal Shiferaw M, Tadele Admasu F, Asmamaw Dejenie T . Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma . Frontiers in Immunology . 13 . 991092 . 2022 . 36119032 . 9479060 . 10.3389/fimmu.2022.991092 . free . doi .
  12. Web site: Carvykti . U.S. Food and Drug Administration (FDA) . 8 March 2022 . 16 March 2022 . 17 March 2022 . https://web.archive.org/web/20220317055159/https://www.fda.gov/vaccines-blood-biologics/carvykti . live .
  13. 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 . 1 March 2022 . 16 March 2022 . 17 March 2022 . https://web.archive.org/web/20220317055744/https://www.jnj.com/u-s-fda-approves-carvykti-ciltacabtagene-autoleucel-janssens-first-cell-therapy-a-bcma-directed-car-t-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma . live .
  14. Research . Center for Biologics Evaluation and . 2024-07-31 . CARVYKTI . FDA . en.
  15. Web site: 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 . 19 April 2024 . 19 April 2024 . https://web.archive.org/web/20240419003946/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed . live .
  16. New gene therapy to treat adult patients with multiple myeloma . European Medicines Agency (EMA) . 25 March 2022 . 25 March 2022 . 25 March 2022 . https://web.archive.org/web/20220325114424/https://www.ema.europa.eu/en/news/new-gene-therapy-treat-adult-patients-multiple-myeloma . live .
  17. Web site: Carvykti: Pending EC decision . European Medicines Agency . 24 March 2022 . 25 March 2022 . 25 March 2022 . https://web.archive.org/web/20220325132503/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/carvykti . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  18. Web site: Carvykti Product information . Union Register of medicinal products . 3 March 2023 . 4 March 2023 . https://web.archive.org/web/20230304070806/https://ec.europa.eu/health/documents/community-register/html/h1648.htm . live .
  19. ((World Health Organization)) . 2020 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84 . WHO Drug Information . 34 . 3 . 10665/340680 . free . World Health Organization .

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