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Amivantamab information


Amivantamab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetEpidermal growth factor receptor (EGFR) and Mesenchymal–epithelial transition (MET)
Clinical data
Trade namesRybrevant
Other namesJNJ-61186372, amivantamab-vmjw
AHFS/Drugs.comMonograph
MedlinePlusa621034
License data
  • US DailyMed: Amivantamab
Pregnancy
category
  • AU: D[1]
Routes of
administration
Intravenous infusion
Drug classAntineoplastic
ATC code
  • L01FX18 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[1]
  • CA: ℞-only / Schedule D[2][3]
  • US: ℞-only[4][5][6]
  • EU: Rx-only[7]
Identifiers
CAS Number
  • 2171511-58-1
DrugBank
  • DB16695
UNII
  • 0JSR7Z0NB6
KEGG
  • D11894
Chemical and physical data
FormulaC6472H10014N1730O2023S46
Molar mass145902.15 g·mol−1

Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer.[4][5][6][7] Amivantamab is a bispecific epidermal growth factor (EGF) receptor-directed and mesenchymal–epithelial transition (MET) receptor-directed antibody. It is the first treatment for adults with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.[5]

The most common side effects include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests.[5][6]

Amivantamab was approved for medical use in the United States in May 2021,[5][6][8][9] and in the European Union in December 2021.[7] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]

  1. ^ a b "Rybrevant (Janssen-Cilag Pty Ltd)". Therapeutic Goods Administration (TGA). 13 January 2023. Archived from the original on 27 March 2023. Retrieved 18 April 2023.
  2. ^ "Rybrevant Product information". Health Canada. 25 April 2012. Archived from the original on 29 June 2022. Retrieved 29 June 2022.
  3. ^ "Summary Basis of Decision - Rybrevant". Health Canada. 23 October 2014. Archived from the original on 6 August 2022. Retrieved 6 August 2022.
  4. ^ a b "Rybrevant- amivantamab injection". DailyMed. Janssen Pharmaceutical Companies. Archived from the original on 26 May 2021. Retrieved 25 May 2021.
  5. ^ a b c d e "FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer". U.S. Food and Drug Administration (FDA) (Press release). 21 May 2021. Archived from the original on 21 May 2021. Retrieved 21 May 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ a b c d Cite error: The named reference FDA amivantamab was invoked but never defined (see the help page).
  7. ^ a b c Cite error: The named reference Rybrevant EPAR was invoked but never defined (see the help page).
  8. ^ "Rybrevant (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations" (Press release). Janssen Pharmaceutical Companies. 21 May 2021. Archived from the original on 21 May 2021. Retrieved 21 May 2021 – via PR Newswire.
  9. ^ "Genmab Announces that Janssen has been Granted U.S. FDA" (Press release). Genmab A/S. 21 May 2021. Archived from the original on 21 May 2021. Retrieved 21 May 2021 – via GlobeNewswire.
  10. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.

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