Teclistamab

Last updated

Teclistamab
Monoclonal antibody
Type Bi-specific T-cell engager
Source Humanized
Target BCMA, CD3
Clinical data
Other namesJNJ-64007957, teclistamab-cqyv
License data
Pregnancy
category
Routes of
administration 		Subcutaneous injection
Drug class Antineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C6383H9847N1695O2003S40
Molar mass 143662.25 g·mol−1

Teclistamab, sold under the brand name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma. [8] 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. [8] [9]

Contents

The most common side effects include hypogammaglobulinemia (low immunoglobulin or antibody levels in the blood, which increases the risk of infection), cytokine release syndrome, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), anemia (low levels of red blood cells or hemoglobin), pain in the muscles and bones, tiredness, thrombocytopenia (low levels of blood platelets, components that help the blood to clot), injection site reactions, upper respiratory tract (nose and throat) infection, lymphopenia (low levels of lymphocytes, a type of white blood cell), diarrhea, pneumonia (infection of the lungs), nausea (feeling sick), fever, headache, cough, constipation and pain. [8]

Teclistamab is the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. [10] Teclistamab was approved for medical use in the European Union in August 2022, [8] [11] and in the United States in October 2022. [10] [12] [13] [14] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [15] [16]

Medical uses

Teclistamab is indicated for the treatment of adults with relapsed and refractory multiple myeloma. [6] [8] [17] [18]

Contraindications

In the US, the prescribing information for teclistamab has a boxed warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). [10] Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%. [10] Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%. [10]

Adverse effects

The most common adverse reactions (≥20%) occurring in the 165 patients in the safety population, were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. [10] The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. [10]

History

Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study. [10] The efficacy population consisted of 110 participants who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy. [10]

The application for teclistamab was granted orphan drug, priority review, and breakthrough therapy designations. [10]

Society and culture

On 21 July 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 Tecvayli, intended for treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies. [8] [9] Tecvayli was reviewed under EMA's accelerated assessment program. [8] The applicant for this medicinal product is Janssen-Cilag International N.V. [8] Teclistamab was approved for medical use in the European Union in August 2022. [8] [19]

Names

Teclistamab is the international nonproprietary name and owned by Genmab A/S (INN). [20]

Related Research Articles

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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.

Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. The company is based in Copenhagen, Denmark – internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, The Netherlands, Genmab U.S., Inc. in Princeton, USA, and Genmab K.K. in Tokyo, Japan. Genmab is a dual-listed company with shares traded on both the Copenhagen Stock Exchange in Denmark and the NASDAQ Global Select Market in the US.

<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.

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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.

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

Nirogacestat, sold under the brand name Ogsiveo, is an anti-cancer medication used for the treatment of desmoid tumors. It is a selective gamma secretase inhibitor that is taken by mouth.

Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. Ciltacabtagene autoleucel is a BCMA -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.

Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma. It bispecifically binds CD20 and CD3 to engage T-cells. It was developed by Genentech.

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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. ↑ "Tecvayli". Therapeutic Goods Administration (TGA). 28 June 2023. Archived from the original on 19 November 2023. Retrieved 10 September 2023.
  2. ↑ "Tecvayli (Janssen-Cilag Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 19 November 2023. Retrieved 10 September 2023.
  3. ↑ "Details for: Tecvayli". Health Canada . 20 October 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  4. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada . 26 October 2023. Archived from the original on 3 January 2024. Retrieved 3 January 2024.
  5. ↑ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA . Retrieved 22 October 2023.
  6. 1 2 "Tecvayli- teclistamab injection". DailyMed. 31 October 2022. Archived from the original on 18 November 2022. Retrieved 18 November 2022.
  7. ↑ "Drug Approval Package: Tecvayli". U.S. Food and Drug Administration (FDA). 23 November 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022.
  8. 1 2 3 4 5 6 7 8 9 10 "Tecvayli EPAR". European Medicines Agency. 18 July 2022. Archived from the original on 10 December 2022. Retrieved 14 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. 1 2 "Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody Tecvayli (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)". Janssen (Press release). 22 July 2022. Archived from the original on 30 July 2022. Retrieved 30 July 2022.
  10. 1 2 3 4 5 6 7 8 9 10 "FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 25 October 2022. Archived from the original on 27 October 2022. Retrieved 28 October 2022.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. ↑ "Janssen Marks First Approval Worldwide for Tecvayli (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma". Janssen Pharmaceutical Companies (Press release). 24 August 2022. Archived from the original on 26 October 2022. Retrieved 26 October 2022.
  12. ↑ "Tecvayli: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 October 2022. Retrieved 27 October 2022.
  13. ↑ "U.S. FDA Approves Tecvayli (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma". Janssen Pharmaceutical Companies. 25 October 2022. Archived from the original on 10 March 2024. Retrieved 26 October 2022.
  14. ↑ Kang C (November 2022). "Teclistamab: First Approval". Drugs. 82 (16): 1613–1619. doi:10.1007/s40265-022-01793-1. PMC   9646474 . PMID   36352205.
  15. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  16. ↑ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  17. ↑ Pan D, Richter J (2023). "Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody". Cancer Management and Research. 15: 741–751. doi: 10.2147/CMAR.S372237 . PMC   10368105 . PMID   37497430.
  18. ↑ Martino EA, Bruzzese A, Labanca C, Mendicino F, Lucia E, Olivito V, Neri A, Morabito F, Vigna E, Gentile M (October 2023). "Teclistamab-cqyv in multiple myeloma". European Journal of Haematology. doi: 10.1111/ejh.14121 . PMID   37848191.
  19. ↑ "Tecvayli Product information". Union Register of medicinal products. 12 December 2022. Archived from the original on 3 March 2023. Retrieved 3 March 2023.
  20. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl: 10665/330879 .
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