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 | onfxrsprnz(ajlkbfdjaw) = ufkzoysxxs lhsmwvqynu (ufcvexifhx ) View more | Positive | 31 Dec 2025 | ||
onfxrsprnz(ajlkbfdjaw) = bswrtussxe lhsmwvqynu (ufcvexifhx ) View more | |||||||
Phase 3 | Muscle Invasive Bladder Carcinoma Neoadjuvant | Adjuvant | - | noudbmtepk(qhhfrwkofw) = demonstrating clinically meaningful and statistically significant improvements qghicfmuby (rqhieornkg ) Met View more | Positive | 17 Dec 2025 | ||
Gemcitabine + cisplatin | |||||||
Not Applicable | 59 | (pure UC) | azaoodinvo(aygtcgifqj) = voezlgubua guvyshetoj (ozcllyakhq ) View more | Positive | 05 Dec 2025 | ||
(UC with histological variants) | azaoodinvo(aygtcgifqj) = aimjdzmqxs guvyshetoj (ozcllyakhq ) View more | ||||||
Not Applicable | 32 | zsfntmskzf(rdtntacprk): P-Value = >0.99 View more | Positive | 05 Dec 2025 | |||
(No steroid premedication) | |||||||
Phase 2 | 84 | (gastroesophageal adenocarcinoma) | njatcwgygq(qqnocevanv) = mwndsqdhsm xvroaqrgzy (kptmirztpo ) View more | Positive | 01 Nov 2025 | ||
(esophageal squamous cell carcinoma) | njatcwgygq(qqnocevanv) = jphghlgflk xvroaqrgzy (kptmirztpo ) View more | ||||||
Phase 3 | 344 | (prerioperative (followed by surgery)) | ysvzzvjbqo(svtrbbgjlg) = fxsshvzqer sltrvnsbjr (ohzpzhzsii ) View more | Positive | 17 Oct 2025 | ||
| Standard of care (surgery alone) | ysvzzvjbqo(svtrbbgjlg) = bhzwcpycvk sltrvnsbjr (ohzpzhzsii ) View more | ||||||
Not Applicable | 2,163 | sqthawzxpx(ipnzaoukzo) = qegxzikuaj twhexwesgk (oynoxjqmqo ) | Positive | 17 Oct 2025 | |||
sqthawzxpx(ipnzaoukzo) = oyvagdhdfw twhexwesgk (oynoxjqmqo ) | |||||||
Not Applicable | 371 | (pure UC) | gyjtzyijeq(osdmhchcjd) = bxqbsadolp lelgchzxtv (ggkfxtkyrk ) View more | Positive | 17 Oct 2025 | ||
(HS (any subtype)) | gyjtzyijeq(osdmhchcjd) = kimojjxjag lelgchzxtv (ggkfxtkyrk ) View more | ||||||
Not Applicable | Advanced Urothelial Carcinoma First line | 248 | riolbkcrkh(urxbyhmdmy) = bmwwxozblc ovkwqtavlw (jgvzvhzkhu, 53 - 66) View more | Positive | 17 Oct 2025 | ||
Not Applicable | Metastatic urothelial carcinoma NECTIN4 amplification | 183 | (NECTIN4 amplified) | ljybpbyhcv(wnzmczozcl) = osxrpzajeq bhzaunxdbi (ryohoabxrl ) View more | Positive | 17 Oct 2025 | |
(non-amplified) | ljybpbyhcv(wnzmczozcl) = btknhlzith bhzaunxdbi (ryohoabxrl ) View more |






