Drug · Adc
Enfortumab Vedotin
CI-DRUG-00000213Explore in graph →NCIt C114500 CHEMBL3301589 CIViC Approved
Regulatory
Approvals (12)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2026-07-10 (see label) | approved | Jul 10, 2026 | openfda |
| US FDA | — | Efficacy supplement 2025-11-21 (see label) | approved | Nov 21, 2025 | openfda |
| US FDA | — | Efficacy supplement 2023-12-15 (see label) | approved | Dec 15, 2023 | openfda |
| US FDA | — | Efficacy supplement 2023-12-15 (see label) | approved | Dec 15, 2023 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 2 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 56 | 36 | 10 | 69 | 12 | CA, EU, US | Dec 18, 2019 | Jul 11, 2011 |
| Malignant Bladder Neoplasm | Approved | Phase 4 | 20 | 14 | 4 | 24 | 2 | EU, US | Dec 18, 2019 | Jun 27, 2018 |
| Malignant Kidney Neoplasm | Phase2 | Phase 2 | 3 | 2 | 0 | 3 | 0 | — | — | Jul 7, 2022 |
| Malignant Penile Neoplasm | Phase2 | Phase 2 | 2 | 2 | 0 | 2 | 0 |
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 27013195
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| NECTIN4 D594H1 | ||||||||
| Enfortumab Vedotin | Malignant Neoplasm | |||||||
Clinical trials
Trials with this intervention (72)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06470282 | Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer | recruiting | Phase 1 / Phase 2 | 47 | University of California, San FranciscoOTHER | 1 | Feb 18, 2026 | clinicaltrials |
| NCT06483334 | A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) |