Ciltacabtagene autoleucel

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Ciltacabtagene autoleucel
Clinical data
Trade names Carvykti
Other namesJNJ-68284528
AHFS/Drugs.com Micromedex Detailed Consumer Information
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administration 		Intravenous
Drug class Antineoplastic
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Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. [8] [10] [11] [12] Ciltacabtagene autoleucel is a BCMA (B-cell maturation antigen)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. [8] [11] Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient. [8] [10] [11]

Contents

The most common adverse reactions include pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting. [11] 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). [10]

Ciltacabtagene autoleucel was approved for medical use in the United States in February 2022, [11] [9] [13] and in the European Union in May 2022. [10]

Medical uses

In the US, ciltacabtagene autoleucel is indicated for the treatment of adults 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. [8] [11]

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. [10]

Adverse effects

In April 2024, the FDA label boxed warning was expanded to include T cell malignancies. [14]

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. [8] [11]

The U.S. Food and Drug Administration (FDA) granted the application for ciltacabtagene autoleucel priority review, breakthrough therapy, and orphan drug designations. [11]

Society and culture

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. [15] [16] The applicant for this medicinal product is Janssen-Cilag International NV. [15] Ciltacabtagene autoleucel was approved for medical use in the European Union in May 2022. [10] [17]

Names

Ciltacabtagene autoleucel is the international nonproprietary name. [18]

Related Research Articles

<span class="mw-page-title-main">Multiple myeloma</span> Cancer of plasma cells

Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, anemia, kidney dysfunction, and infections may occur. Complications may include hypercalcemia and amyloidosis.

<span class="mw-page-title-main">Bortezomib</span> Chemical compound

Bortezomib, sold under the brand name Velcade among others, is an anti-cancer medication used to treat multiple myeloma and mantle cell lymphoma. This includes multiple myeloma in those who have and have not previously received treatment. It is generally used together with other medications. It is given by injection.

Takeda Oncology is a biopharmaceutical company based in Cambridge, Massachusetts. It is a fully owned subsidiary of Takeda Pharmaceutical.

<span class="mw-page-title-main">B-cell maturation antigen</span> Protein-coding gene in the species Homo sapiens

B-cell maturation antigen, also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17), is a protein that in humans is encoded by the TNFRSF17 gene.

<span class="mw-page-title-main">Pomalidomide</span> Chemical compound

Pomalidomide, sold under the brand names Pomalyst and Imnovid, is an anti-cancer medication used for the treatment of multiple myeloma and AIDS-related Kaposi sarcoma.

<span class="mw-page-title-main">Carfilzomib</span> Chemical compound

Carfilzomib, sold under the brand name Kyprolis, is an anti-cancer medication acting as a selective proteasome inhibitor. Chemically, it is a tetrapeptide epoxyketone and an analog of epoxomicin. It was developed by Onyx Pharmaceuticals.

<span class="mw-page-title-main">Daratumumab</span> Monoclonal antibody

Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38, which is overexpressed in multiple myeloma cells. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.

<span class="mw-page-title-main">Isatuximab</span> Monoclonal antibody

Isatuximab, sold under the brand name Sarclisa, is a monoclonal antibody (mAb) medication for the treatment of multiple myeloma.

<span class="mw-page-title-main">Ixazomib</span> Chemical compound

Ixazomib is a drug for the treatment of multiple myeloma, a type of white blood cell cancer, in combination with other drugs. It is taken by mouth in the form of capsules.

<span class="mw-page-title-main">Melphalan flufenamide</span> Alkylating type cancer drug

Melphalan flufenamide, sold under the brand names Pepaxto and Pepaxti, is an anticancer medication used to treat multiple myeloma.

Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat B-cell lymphoma.

<span class="mw-page-title-main">Selinexor</span> Anti-cancer drug

Selinexor sold under the brand name Xpovio among others, is a selective inhibitor of nuclear export used as an anti-cancer medication. It works by blocking the action of exportin 1 and thus blocking the transport of several proteins involved in cancer-cell growth from the cell nucleus to the cytoplasm, which ultimately arrests the cell cycle and leads to apoptosis. It is the first drug with this mechanism of action.

bluebird bio, Inc., based in Somerville, Massachusetts, is a biotechnology company that develops gene therapies for severe genetic disorders.

Brexucabtagene autoleucel, sold under the brand name Tecartus, is a cell-based gene therapy medication for the treatment of mantle cell lymphoma (MCL) and acute lymphoblastic leukemia (ALL).

Belantamab mafodotin, sold under the brand name Blenrep, is a medication for the treatment of relapsed and refractory multiple myeloma.

Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma.

Teclistamab, sold under the brand name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma. It is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells.

Talquetamab, sold under the brand name Talvey, is a humanized monoclonal antibody used for the treatment of multiple myeloma. It is a bispecific GPRC5D-directed CD3 T-cell engager. Talquetamab is a bispecific antibody against two targets: human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen with potential antineoplastic activity. Talquetamab binds both targets, drawing the T cells close to the tumor cells, causing a cytotoxic T-lymphocyte response. It is being developed by Janssen Pharmaceuticals.

Elranatamab, sold under the brand name Elrexfio, is a medication used for the treatment of multiple myeloma. Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. Elranatamab is administered subcutaneously.

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. 1 2 3 4 5 6 "Carvykti- ciltacabtagene autoleucel injection, suspension". DailyMed . 9 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
  9. 1 2 "Carvykti". U.S. Food and Drug Administration (FDA). 8 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
  10. 1 2 3 4 5 6 7 "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. 1 2 3 4 5 6 7 8 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  12. ↑ 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.
  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 (Press release). 1 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
  14. ↑ "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  15. 1 2 "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.
  16. ↑ "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.
  17. ↑ "Carvykti Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  18. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl: 10665/340680 .
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