Enfortumab vedotin

Enfortumab vedotin,[1] sold under the brand name Padcev, is an antibody-drug conjugate[2] designed for the treatment of cancer expressing Nectin-4.[3] Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.

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
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

The most common side effects are 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.[4]

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.[5]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6]

Approvals

Results of a Phase I clinical trial were reported in 2016.[2]

In December 2019, enfortumab vedotin-ejfv was approved in the United States for the treatment of adult patients with locally advanced or metastatic urothelial cancer who had previously received a programmed cell death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.[4][7]

Enfortumab vedotin was approved based on the results of a clinical trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy.[4][7] The overall response rate, reflecting the percentage of patients who had a certain amount of tumor shrinkage, was 44%, with 12% having a complete response and 32% having a partial response.[4] The median duration of response was 7.6 months.[4]

The application for enfortumab vedotin-ejfv was granted accelerated approval, priority review designation, and breakthrough therapy designation.[4] The U.S. Food and Drug Administration (FDA) granted the approval of Padcev to Astellas Pharma US Inc.[4]

References
  1. World Health Organization (2013). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 109" (PDF). WHO Drug Information. 27 (2).
  2. Seattle Genetics and Agensys, an Affiliate of Astellas, Highlight Promising Enfortumab Vedotin (ASG-22ME) and ASG-15ME Phase 1 Data in Metastatic Urothelial Cancer at 2016 ESMO Congress. Oct 2016
  3. Statement On A Nonproprietary Name Adopted By The USAN Council - Enfortumab Vedotin, American Medical Association.
  4. "FDA approves new type of therapy to treat advanced urothelial cancer". U.S. Food and Drug Administration (FDA) (Press release). 18 December 2019. Archived from the original on 19 December 2019. Retrieved 18 December 2019. This article incorporates text from this source, which is in the public domain.
  5. Challita-Eid PM, Satpayev D, Yang P, 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.
  6. "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.
  7. "Drug Trials Snapshots: Padcev". U.S. Food and Drug Administration (FDA). 13 December 2019. Retrieved 24 January 2020. This article incorporates text from this source, which is in the public domain.
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