Chemistry:Teclistamab

From HandWiki
Short description: Monoclonal antibody
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.[6] 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.[6][7]

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.[6]

Teclistamab is the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[8] Teclistamab was approved for medical use in the European Union in August 2022,[6][9] and in the United States in October 2022.[8][10][11][12] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13][14]

Medical uses

Teclistamab is indicated for the treatment of adults with relapsed and refractory multiple myeloma.[4][6][15][16]

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).[8] Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%.[8] Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%.[8]

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.[8] The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.[8]

History

Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study.[8] 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.[8]

The application for teclistamab was granted orphan drug, priority review, and breakthrough therapy designations.[8]

Society and culture

Legal status

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.[6][7] Tecvayli was reviewed under EMA's accelerated assessment program.[6] The applicant for this medicinal product is Janssen-Cilag International N.V.[6] Teclistamab was approved for medical use in the European Union in August 2022.[6][17]

Names

Teclistamab is the international nonproprietary name (INN).[18]

References

  1. ↑ "Tecvayli". 28 June 2023. https://www.tga.gov.au/resources/auspmd/tecvayli. 
  2. ↑ "Tecvayli (Janssen-Cilag Pty Ltd)". 28 July 2023. https://www.tga.gov.au/resources/prescription-medicines-registrations/tecvayli-janssen-cilag-pty-ltd. 
  3. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26"]. 26 October 2023. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-10-26.html. 
  4. ↑ 4.0 4.1 "Tecvayli- teclistamab injection". 31 October 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e. 
  5. ↑ "Drug Approval Package: Tecvayli". U.S. Food and Drug Administration (FDA). 23 November 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761291Orig1s000TOC.cfm. 
  6. ↑ 6.0 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 "Tecvayli EPAR". 18 July 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ↑ 7.0 7.1 "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.
  8. ↑ 8.0 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 "FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 25 October 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma.  This article incorporates text from this source, which is in the public domain.
  9. ↑ "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. Retrieved 26 October 2022.
  10. ↑ "Tecvayli: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761291. 
  11. ↑ "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". 25 October 2022. https://www.jnj.com/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. 
  12. ↑ "Teclistamab: First Approval". Drugs 82 (16): 1613–1619. November 2022. doi:10.1007/s40265-022-01793-1. PMID 36352205. 
  13. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". 10 January 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022.  This article incorporates text from this source, which is in the public domain.
  14. ↑ (PDF) New Drug Therapy Approvals 2022 (Report). January 2024. https://www.fda.gov/media/164429/download. Retrieved 14 January 2024.  This article incorporates text from this source, which is in the public domain.
  15. ↑ "Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody". Cancer Management and Research 15: 741–751. 2023. doi:10.2147/CMAR.S372237. PMID 37497430. 
  16. ↑ "Teclistamab-cqyv in multiple myeloma". European Journal of Haematology. October 2023. doi:10.1111/ejh.14121. PMID 37848191. 
  17. ↑ "Tecvayli Product information". 12 December 2022. https://ec.europa.eu/health/documents/community-register/html/h1675.htm. 
  18. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information 33 (3). 2019. 



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