Enfortumab vedotin

Enfortumab vedotin
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetNectin-4
Clinical data
Trade namesPadcev
Other namesAGS-22M6E, AGS-22CE, enfortumab vedotin-ejfv
AHFS/Drugs.comMonograph
MedlinePlusa620005
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6642H10284N1742O2063S46
Molar mass149024.23 g·mol−1

Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate[6] used for the treatment of urothelial cancer.[4][7] It is a nectin-4-directed antibody and microtubule inhibitor conjugate.[4][7] Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.[5]

The most common side effects include fatigue, peripheral neuropathy (nerve damage resulting in tingling or numbness), decreased appetite, rash, alopecia (hair loss), nausea, altered taste, diarrhea, dry eye, pruritus (itching) and dry skin.[7]

The fully humanized antibody was created by scientists at Agensys (part of Astellas) using Xenomice from Amgen; the linker technology holding the antibody and the toxin together was provided by and licensed from Seattle Genetics.[8]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

  1. ^ a b "Padcev APMDS". Therapeutic Goods Administration (TGA). 21 July 2022. Archived from the original on 21 July 2022. Retrieved 2 August 2022.
  2. ^ "Padcev (Astellas Pharma Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 13 March 2025. Retrieved 24 March 2025.
  3. ^ "Summary Basis of Decision (SBD) for Padcev". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  4. ^ a b c "Padcev ejfv- enfortumab vedotin injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 11 December 2021. Retrieved 18 December 2021.
  5. ^ a b Cite error: The named reference Padcev EPAR was invoked but never defined (see the help page).
  6. ^ Cite error: The named reference Ph1 was invoked but never defined (see the help page).
  7. ^ a b c Cite error: The named reference FDA PR was invoked but never defined (see the help page).
  8. ^ Challita-Eid PM, Satpayev D, Yang P, An Z, Morrison K, Shostak Y, et al. (May 2016). "Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models". Cancer Research. 76 (10): 3003–13. doi:10.1158/0008-5472.can-15-1313. PMID 27013195. Archived from the original on 25 August 2021. Retrieved 19 January 2017.
  9. ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.
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