Pembrolizumab

Pembrolizumab
From PDB entry 5dk3
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetPD-1
Clinical data
Trade namesKeytruda
Other namesMK-3475, lambrolizumab
AHFS/Drugs.comMonograph
MedlinePlusa614048
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.234.370 Edit this at Wikidata
Chemical and physical data
FormulaC6534H10004N1716O2036S46
Molar mass146648.64 g·mol−1

Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody, more specifically a PD-1 Inhibitor, used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer.[12][14][15][16] It is administered by slow intravenous injection.[15]

Common side effects include fatigue, musculoskeletal pain, decreased appetite, itchy skin (pruritus), diarrhea, nausea, rash, fever (pyrexia), cough, difficulty breathing (dyspnea), constipation, pain, and abdominal pain.[17][15] It is an IgG4 isotype antibody that blocks a protective mechanism of cancer cells, allowing the immune system to destroy them. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes.[17]

Pembrolizumab was approved for medical use in the United States in 2014.[15] It is on the World Health Organization's List of Essential Medicines.[18]

  1. ^ "Pembrolizumab (Keytruda) Use During Pregnancy". Drugs.com. 24 September 2019. Archived from the original on 14 June 2020. Retrieved 10 January 2020.
  2. ^ "Keytruda, Microsatellite instability-high cancer". Department of Health and Aged Care, Commonwealth of Australia. Archived from the original on 22 November 2022.
  3. ^ "Keytruda, Oesophageal Cancer". Department of Health and Aged Care, Commonwealth of Australia. Archived from the original on 22 November 2022.
  4. ^ "Keytruda (pembrolizumab) is indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with Stage IIB, IIC, or III melanoma who have undergone complete resection". Department of Health and Aged Care, Commonwealth of Australia. Archived from the original on 18 March 2023. Retrieved 18 March 2023.
  5. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  6. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 31 March 2024. Retrieved 31 March 2024.
  7. ^ "KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd) - 26". Department of Health and Aged Care.
  8. ^ "KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd) - 27". Department of Health and Aged Care.
  9. ^ "Regulatory Decision Summary for Keytruda". Health Canada. 6 February 2024. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  10. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Archived from the original on 20 February 2020. Retrieved 7 April 2024.
  11. ^ "Keytruda 50 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 7 April 2020. Archived from the original on 13 December 2017. Retrieved 30 April 2020.
  12. ^ a b Cite error: The named reference Keytruda label was invoked but never defined (see the help page).
  13. ^ Cite error: The named reference Keytruda EPAR was invoked but never defined (see the help page).
  14. ^ "FDA approves pembrolizumab combination for the first-line treatment of cervical cancer". U.S. Food and Drug Administration. 13 October 2021. Archived from the original on 13 October 2021. Retrieved 15 October 2021.
  15. ^ a b c d "Pembrolizumab Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 14 June 2020. Retrieved 15 July 2019.
  16. ^ "FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer". U.S. Food and Drug Administration. 11 August 2021. Archived from the original on 28 July 2021. Retrieved 28 July 2021.
  17. ^ a b Cite error: The named reference FDA PR 20200629 was invoked but never defined (see the help page).
  18. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.