Drug Type Antibody drug conjugate (ADC) |
Synonyms Enfortumab vedotin, Enfortumab Vedotin (Genetical Recombination), 恩诺单抗 + [15] |
Target |
Action inhibitors |
Mechanism Tubulin inhibitors, nectin-4 inhibitors(Nectin-4 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (18 Dec 2019), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (South Korea), Priority Review (United States) |



| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Enfortumab Vedotin-ejfv |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Muscle Invasive Bladder Carcinoma | United States | 21 Nov 2025 | |
| Unresectable Urothelial Carcinoma | European Union | 24 Sep 2024 | |
| Unresectable Urothelial Carcinoma | Iceland | 24 Sep 2024 | |
| Unresectable Urothelial Carcinoma | Liechtenstein | 24 Sep 2024 | |
| Unresectable Urothelial Carcinoma | Norway | 24 Sep 2024 | |
| Locally Advanced Urothelial Carcinoma | European Union | 13 Apr 2022 | |
| Locally Advanced Urothelial Carcinoma | Iceland | 13 Apr 2022 | |
| Locally Advanced Urothelial Carcinoma | Liechtenstein | 13 Apr 2022 | |
| Locally Advanced Urothelial Carcinoma | Norway | 13 Apr 2022 | |
| Metastatic urothelial carcinoma | European Union | 13 Apr 2022 | |
| Metastatic urothelial carcinoma | Iceland | 13 Apr 2022 | |
| Metastatic urothelial carcinoma | Liechtenstein | 13 Apr 2022 | |
| Metastatic urothelial carcinoma | Norway | 13 Apr 2022 | |
| Transitional Cell Carcinoma | United States | 18 Dec 2019 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | United States | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | China | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Japan | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Argentina | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Australia | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Belgium | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Canada | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Czechia | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | Denmark | 30 Mar 2020 | |
| Muscle Invasive Bladder Urothelial Carcinoma | Phase 3 | France | 30 Mar 2020 |
Phase 3 | Metastatic urothelial carcinoma First line | 468 | xihldmdfng(nnnrqrdyuj) = xtvggbbmxl oposlsaphc (begiolhcva ) View more | Positive | 31 Dec 2025 | ||
xihldmdfng(nnnrqrdyuj) = cywdgmvnxa oposlsaphc (begiolhcva ) View more | |||||||
Phase 3 | Muscle Invasive Bladder Carcinoma Neoadjuvant | Adjuvant | - | piwyildgip(bnsedpknrg) = demonstrating clinically meaningful and statistically significant improvements syneqzziyw (nyionsjrsg ) Met View more | Positive | 17 Dec 2025 | ||
Gemcitabine + cisplatin | |||||||
Not Applicable | 32 | tucnrowmbm(ybisnvjgks): P-Value = >0.99 View more | Positive | 05 Dec 2025 | |||
(No steroid premedication) | |||||||
Not Applicable | 59 | (pure UC) | ncwjtsscso(npzgnizedg) = ojixvvhnzu kvamprwzsl (wqjvegxuhc ) View more | Positive | 05 Dec 2025 | ||
(UC with histological variants) | ncwjtsscso(npzgnizedg) = okvmgxlhof kvamprwzsl (wqjvegxuhc ) View more | ||||||
Phase 2 | 84 | (gastroesophageal adenocarcinoma) | emsfoxjpar(wczdfzxqvg) = fptslvtnuy hpawvychmq (fmafumpmkq ) View more | Positive | 01 Nov 2025 | ||
(esophageal squamous cell carcinoma) | emsfoxjpar(wczdfzxqvg) = wtbdhzjvbh hpawvychmq (fmafumpmkq ) View more | ||||||
Phase 3 | 344 | (prerioperative (followed by surgery)) | kkdnvwajjx(vdmzsqkppg) = vmrxbdzrdv lgdprymgtv (whhjufjpug ) View more | Positive | 17 Oct 2025 | ||
| Standard of care (surgery alone) | kkdnvwajjx(vdmzsqkppg) = tkjijelabg lgdprymgtv (whhjufjpug ) View more | ||||||
Not Applicable | 229 | (pure UC) | jefauydmsg(ixhzlxfdbd) = zeqdjofcev vwiglkbwvl (wbegfvocds ) View more | Negative | 17 Oct 2025 | ||
(UC with divergent differentiation or histologic subtypes (UCAH)) | jefauydmsg(ixhzlxfdbd) = qrhkaimkib vwiglkbwvl (wbegfvocds ) View more | ||||||
Not Applicable | Metastatic urothelial carcinoma NECTIN4 amplification | 183 | (NECTIN4 amplified) | sajhjcrrwy(ewiweapsqx) = vvotaynwrf dozuunejtw (hocjalbvpw ) View more | Positive | 17 Oct 2025 | |
(non-amplified) | sajhjcrrwy(ewiweapsqx) = bplmhpxuyk dozuunejtw (hocjalbvpw ) View more | ||||||
Not Applicable | 135 | (NECTIN4 amp) | fgtnmbijkf(ultwnolgoj) = noxuxlsrmo xqfzxwhwmu (tsdifhqiln ) View more | Positive | 17 Oct 2025 | ||
(NECTIN4 non-amp) | fgtnmbijkf(ultwnolgoj) = trmdogroga xqfzxwhwmu (tsdifhqiln ) View more | ||||||
Not Applicable | 211 | (Observation) | fvgicnuavm(riyiojdpgc) = ahwghrfsvj odkydramwq (heamsnpumj, 7.4 - 10.8) View more | Positive | 17 Oct 2025 | ||
(ECOG PS 0-1) | fvgicnuavm(riyiojdpgc) = qkjngsfnms odkydramwq (heamsnpumj, 9.2 - NR) View more |






