Enfortumab vedotin
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Nectin-4 |
| Clinical data | |
| Trade names | Padcev |
| Other names | AGS-22M6E, AGS-22CE, enfortumab vedotin-ejfv |
| License data |
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| Routes of administration | IV |
| ATC code |
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| Legal status | |
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| Identifiers | |
| CAS Number | |
| PubChem SID | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6642H10284N1742O2063S46 |
| Molar mass | 149024.23 g·mol−1 |
Enfortumab vedotin[2] (AGS-22M6E) 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, pruritis (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]
Results of a Phase I clinical trial were reported in 2016.[3]
Approvals
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][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.[5][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.[5] The median duration of response was 7.6 months.[5]
The application for enfortumab vedotin-ejfv was granted accelerated approval, priority review designation, and breakthrough therapy designation.[5] The U.S. Food and Drug Administration (FDA) granted the approval of Padcev to Astellas Pharma US Inc.[5]
References
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ World Health Organization (2013). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 109" (PDF). WHO Drug Information. 27 (2).
- ^ 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
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Enfortumab Vedotin, American Medical Association.
- ^ 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.
This article incorporates text from this source, which is in the public domain.
- ^ 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.
- ^ a b "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.
External links
- "Enfortumab vedotin". Drug Information Portal. U.S. National Library of Medicine.
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