Back إنفورتوماب فيدوتين Arabic Enfortumab-Vedotin German انفورتومب ودوتین FA エンホルツマブ ベドチン Japanese ଏନଫୋର୍ଟୁମାବ ଭେଡୋଟିନ OR Энфортумаб ведотин Russian
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Nectin-4 |
| Clinical data | |
| Trade names | Padcev |
| Other names | AGS-22M6E, AGS-22CE, enfortumab vedotin-ejfv |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620005 |
| License data | |
| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6642H10284N1742O2063S46 |
| Molar mass | 149024.23 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]
- ^ a b "Padcev APMDS". Therapeutic Goods Administration (TGA). 21 July 2022. Archived from the original on 21 July 2022. Retrieved 2 August 2022.
- ^ "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.
- ^ "Summary Basis of Decision (SBD) for Padcev". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ 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.
- ^ a b Cite error: The named reference
Padcev EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Ph1was invoked but never defined (see the help page). - ^ a b c Cite error: The named reference
FDA PRwas invoked but never defined (see the help page). - ^ 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.
- ^ "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.