Enfortumab vedotin

From Wikipedia, the free encyclopedia

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
  • 1346452-25-2 checkY
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6642H10284N1742O2063S46
Molar mass149024.23 g·mol−1

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

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.[5]

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.[6]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]

History[]

Results of a Phase I clinical trial were reported in 2016.[3]

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.[5][8]

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.[5][8] 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.[5] The median duration of response was 7.6 months.[5]

The U.S. Food and Drug Administration (FDA) granted the application for enfortumab vedotin-ejfv accelerated approval, priority review designation, and breakthrough therapy designation.[5] The FDA granted the approval of Padcev to Astellas Pharma US Inc.[5]

In July 2021, the FDA approved enfortumab vedotin for adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or; are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.[9]

Society and culture[]

Legal status[]

On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Padcev, intended for the treatment of adult patients with urothelial cancer.[10] The applicant for this medicinal product is Astellas Pharma Europe B.V.[10]

References[]

  1. ^ "Padcev ejfv- enfortumab vedotin injection, powder, lyophilized, for solution". DailyMed. Retrieved 18 December 2021.
  2. ^ World Health Organization (2013). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 109" (PDF). WHO Drug Information. 27 (2).
  3. ^ a b 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
  4. ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Enfortumab Vedotin, American Medical Association.
  5. ^ a b c d e f g "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. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ 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.
  7. ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.
  8. ^ a b "Drug Trials Snapshots: Padcev". U.S. Food and Drug Administration (FDA). 13 December 2019. Retrieved 24 January 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ "FDA grants regular approval to enfortumab vedotin-ejfv for locally adv". U.S. Food and Drug Administration (FDA). 9 July 2021. Retrieved 9 July 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ a b "Padcev: Pending EC decision". European Medicines Agency. 16 December 2021. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links[]


Stub icon

This monoclonal antibody–related article is a stub. You can help Wikipedia by .

  • v
  • t
Retrieved from ""