Teclistamab

Teclistamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetBCMA, CD3
Clinical data
Other namesJNJ-64007957, teclistamab-cqyv
License data
Pregnancy
category
Routes of
administration		Subcutaneous injection
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6383H9847N1695O2003S40
Molar mass143662.25 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]

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]

  1. ^ "Tecvayli". Therapeutic Goods Administration (TGA). 28 June 2023. Archived from the original on 19 November 2023. Retrieved 10 September 2023.
  2. ^ "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.
  3. ^ "Tecvayli (Janssen-Cilag Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 19 November 2023. Retrieved 10 September 2023.
  4. ^ "Details for: Tecvayli". Health Canada. 20 October 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  5. ^ "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.
  6. ^ "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. ^ a b c d e "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. ^ Cite error: The named reference Janssen PR 20220722 was invoked but never defined (see the help page).
  10. ^ a b "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. Public Domain 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. Public Domain 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. Public Domain This article incorporates text from this source, which is in the public domain.