Nivolumab

Nivolumab
Fab fragment of nivolumab (blue) binding the extracellular domain of PD-1 (purple). From PDB entry 5ggr.
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetPD-1
Clinical data
Trade namesOpdivo
Other namesONO-4538, BMS-936558, MDX1106
AHFS/Drugs.comMonograph
MedlinePlusa614056
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classImmunotherapy[3]
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life27 days[9]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6362H9862N1712O1995S42
Molar mass143599.39 g·mol−1

Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication used to treat a number of types of cancer.[2] This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer.[9][10][2][11][12] It is administered intravenously.[9][10][2]

The most common side effects include fatigue, rash, musculoskeletal pain, pruritus (itching), diarrhea, nausea, asthenia (weakness), cough, dyspnea (shortness of breath), constipation, decreased appetite, back pain, arthralgia (joint pain), upper respiratory tract infection, pyrexia (fever), headache, abdominal pain, and vomiting.[12] Use during pregnancy may harm the baby.[1][2] Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1.[2] It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.[2][3] The most common side effects when used in combination with chemotherapy include peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.[11]

Nivolumab was approved for medical use in the United States in 2014.[2][9] It is on the World Health Organization's List of Essential Medicines.[13] It is made using Chinese hamster ovary cells.[14] Nivolumab is the second FDA-approved systemic therapy for mesothelioma[15] and is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.[11]

  1. ^ a b c "Nivolumab (Opdivo) Use During Pregnancy". Drugs.com. 4 November 2019. Retrieved 11 March 2020.
  2. ^ a b c d e f g h "Nivolumab Monograph for Professionals". Drugs.com. Retrieved 14 November 2019.
  3. ^ a b "Nivolumab (Opdivo)". Cancer Research UK. Retrieved 15 December 2019.
  4. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  5. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
  6. ^ "Regulatory Decision Summary for Opdivo". Drug and Health Products Portal. 29 December 2023. Retrieved 2 April 2024.
  7. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
  8. ^ "Opdivo 10 mg/mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 24 August 2020. Retrieved 2 October 2020.
  9. ^ a b c d e Cite error: The named reference Opdivo FDA label was invoked but never defined (see the help page).
  10. ^ a b c Cite error: The named reference Opdivo EPAR was invoked but never defined (see the help page).
  11. ^ a b c Cite error: The named reference FDA PR 20210416 was invoked but never defined (see the help page).
  12. ^ a b Cite error: The named reference FDA nivolumab 20210520 was invoked but never defined (see the help page).
  13. ^ 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.
  14. ^ Rajan A, Kim C, Heery CR, Guha U, Gulley JL (September 2016). "Nivolumab, anti-programmed death-1 (PD-1) monoclonal antibody immunotherapy: Role in advanced cancers". Human Vaccines & Immunotherapeutics. 12 (9): 2219–31. doi:10.1080/21645515.2016.1175694. PMC 5027703. PMID 27135835.
  15. ^ Cite error: The named reference FDA PR 20201002 was invoked but never defined (see the help page).