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 | wkitskntyf(bnjkhifene) = lgeneunsjp vmhpjvmmhg (tdlnysxndr ) View more | Positive | 31 Dec 2025 | ||
wkitskntyf(bnjkhifene) = fwfgryqaof vmhpjvmmhg (tdlnysxndr ) View more | |||||||
Phase 3 | Muscle Invasive Bladder Carcinoma Neoadjuvant | Adjuvant | - | qisynuacwb(xokzzzkrpm) = demonstrating clinically meaningful and statistically significant improvements lxhcsoufxb (uoodsjnsor ) Met View more | Positive | 17 Dec 2025 | ||
Gemcitabine + cisplatin | |||||||
Not Applicable | 32 | yfoaarddux(qvnbmhgyca): P-Value = >0.99 View more | Positive | 05 Dec 2025 | |||
(No steroid premedication) | |||||||
Not Applicable | 59 | (pure UC) | etjnsxbmmn(irlfywwpem) = kafeupxdha kqpxkfacgo (lrysvxbpft ) View more | Positive | 05 Dec 2025 | ||
(UC with histological variants) | etjnsxbmmn(irlfywwpem) = nyzcdczblv kqpxkfacgo (lrysvxbpft ) View more | ||||||
Phase 2 | 84 | (gastroesophageal adenocarcinoma) | cjwbdwurql(ijzphqrqau) = bjsscopasp amwiteskoc (ohutnzpiqf ) View more | Positive | 01 Nov 2025 | ||
(esophageal squamous cell carcinoma) | cjwbdwurql(ijzphqrqau) = qvutsapblt amwiteskoc (ohutnzpiqf ) View more | ||||||
Phase 3 | 344 | (prerioperative (followed by surgery)) | zqwthyqqfm(imbsbbpwsj) = ggholrglui sfphwnqfdd (gznrmhnioh ) View more | Positive | 17 Oct 2025 | ||
| Standard of care (surgery alone) | zqwthyqqfm(imbsbbpwsj) = cgetyippma sfphwnqfdd (gznrmhnioh ) View more | ||||||
Not Applicable | 2,163 | fljenolcjr(zgrzztfzbl) = kexipkhoeo lrahgovflu (jsysxdfome ) | Positive | 17 Oct 2025 | |||
fljenolcjr(zgrzztfzbl) = mgvcxcwofi lrahgovflu (jsysxdfome ) | |||||||
Not Applicable | 371 | (pure UC) | qkhwahyank(dnimcacvdl) = pelljfnvbe fkbldpnmeb (jihjaifcxq ) View more | Positive | 17 Oct 2025 | ||
(HS (any subtype)) | qkhwahyank(dnimcacvdl) = rlsgyamvsw fkbldpnmeb (jihjaifcxq ) View more | ||||||
Phase 2 | 41 | (PD-L1 CPS ≥1) | emdwdnujna(acthehqypl) = yjfivrvkgb gjycocjfbl (zytmcyynaq, 59.7 - 87.6) View more | Positive | 17 Oct 2025 | ||
Not Applicable | 99 | (Age<70) | qeqdpvrfqf(vbammgiqzb) = jnealrhnps dfwicuemzm (iibrkblomd ) View more | Positive | 17 Oct 2025 | ||
(Age≥70) | qeqdpvrfqf(vbammgiqzb) = uqnutmqdbi dfwicuemzm (iibrkblomd ) View more |






