Data updated: May 26, 2026
PADCEV (enfortumab vedotin-ejfv)
Trial Activity: Growth 43 active trials
First-in-Class Breakthrough Therapy Priority Review Accelerated Approval
Oncology
Approved 2019-12-18
Development Insights
Astellas Pharma Global Development, Inc. conducting 8 trials (15%)
100 indications explored (Broad Platform)
→ urothelial carcinoma (8 trials)
→ metastatic urothelial carcinoma (7 trials)
→ bladder cancer (7 trials)
5
Indications
--
Phase 3 Trials
5
Priority Reviews
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-12-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PADCEV Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2019 to 2025 · 4 indication expansions
What PADCEV Treats
5 FDA approvalsOriginally approved for its first indication in 2019 . Covers 5 distinct patient populations.
- Other (5)
PADCEV Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
55 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06311214 | NCI-2024-01903 NCI-2024-01903, 2025-0022 | Ph 2 | recruiting | Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) |
| NCT04963153 | NCI-2021-07069 NCI-2021-07069, MCC 21460 | Ph 1 | active not recruiting | Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy |
| NCT05239624 | 21-316 | Ph 2 | recruiting | Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer |
| NCT05868265 | 21-393 | Ph 2 | recruiting | A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract |
| NCT05614739 FORAGER-1 | 18594 J4G-OX-JZVA, 2022-502755-59-00 | Ph 1 | recruiting | FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3 |
| NCT06041503 | 10001533 001533-C | Ph 2 | recruiting | Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE) |
| NCT07566156 | C5701009 EV-309, 2026-525612-34-00 | Ph 3 | recruiting | Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) |
| NCT07087860 RECIPE-B1 | MC220503 22-006413 | Ph 2 | recruiting | Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers |
| NCT04878029 | STUDY00002329 NCI-2021-01365, STUDY00002329 | Ph 1 | recruiting | Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer |
| NCT07287995 | 2998-CL-0101 2025-524567-21 | Ph 1, Ph 2 | recruiting | A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors |
| NCT07421700 | C6461006 2025-523523-21-00, Symbiotic-GU-06 | Ph 1, Ph 2 | recruiting | Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer |
| NCT07110038 | UKT-IKF-DEPECA-1 2025-521644-37-00 | Ph 2 | recruiting | DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma |
| NCT07475806 | 7465-CL-0209 | Ph 2 | recruiting | A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder |
| NCT04960709 VOLGA | D910PC00001 2020-005452-38 | Ph 3 | active not recruiting | Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin |
| NCT04225117 results posted | 7465-CL-202 KEYNOTE-F21, MK-3475-F21 | Ph 2 | active not recruiting | A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) |
| NCT06145308 | NCC4132 | Ph 2 | recruiting | Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing |
| NCT06553885 | MCC-23188 | Ph 2 | recruiting | Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC |
| NCT06891560 | 24-215 | Ph 2 | recruiting | A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma |
| NCT05923190 | 23-1008 GU-217 | Ph 2 | active not recruiting | Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma |
| NCT03547973 TROPHY U-01 | IMMU-132-06 2023-508302-24 | Ph 2 | recruiting | Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread |
| NCT07347314 ENVELOPE | NCCH2412/MK015 | Ph 2 | recruiting | Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy |
| NCT06862219 | 7465-CL-4001 | Ph 4 | recruiting | A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer |
| NCT06434350 | 2024-0071 NCI-2024-04592 | Ph 1, Ph 2 | recruiting | Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) |
| NCT06809140 | HCRN-GU22-598 | Ph 2 | recruiting | Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer |
| NCT07221942 IMPROEV | 25-1029 GU-229 | Ph 2 | recruiting | Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma |
| NCT06483334 | 3475-04C MK-3475-04C, 2023-506387-14-00 | Ph 1, Ph 2 | active not recruiting | 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) |
| NCT06470282 | 24522 NCI-2024-04701 | Ph 1, Ph 2 | recruiting | Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer |
| NCT06764095 | MC240504 NCI-2024-10405, 24-006857 | Ph 4 | recruiting | Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial |
| NCT04754191 ENCORE | HCI137651 | Ph 2 | active not recruiting | Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer |
| NCT05775471 | 22-001932 NCI-2023-00999 | Ph 2 | recruiting | Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer |
| NCT07374549 | SYS6002-00X | Ph 2 | not yet recruiting | SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma |
| NCT03869190 | WO39613 | Ph 1, Ph 2 | completed | Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) |
| NCT07139977 EV-4-EC | PRO00055484 | Ph 2 | not yet recruiting | Study of EV for Recurrent Endometrial Carcinoma |
| NCT06305767 | V940-005 V940-005, U1111-1292-1952 | Ph 1, Ph 2 | active not recruiting | A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) |
| NCT03474107 results posted | 7465-CL-0301 2017-003344-21, jRCT2080224027 | Ph 3 | completed | A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) |
| NCT05656235 | J2249 IRB00327710 | Ph 2 | recruiting | Renal Retention in High Grade Upper Tract Urothelial Cancer |
| NCT06104618 | MC200505 NCI-2023-08624, 20-011329 | Ph 2 | recruiting | Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis |
| NCT05014139 | SGN22E-004 EV-104, C5701004 | Ph 1 | terminated | A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) |
| NCT04887870 | CA248-0003 CA248-0003, 516-014 | Ph 2, Ph 3 | completed | Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study |
| NCT04995419 results posted | 7465-CL-1104 CTR20210922 | Ph 2 | completed | A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy |
| NCT06906822 PlugIN | GEM 2303 2024-514163-26-00 | Ph 2 | recruiting | PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients |
| NCT06394570 STAR-EV | STU-2024-0374 | Ph 1, Ph 2 | recruiting | Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer |
| NCT03924895 | 3475-905 MK-3475-905, KEYNOTE-905 | Ph 3 | active not recruiting | Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) |
| NCT06356155 NEPTUNE | UMCC 2023.011 | Ph 2 | recruiting | Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer |
| NCT05756569 | STUDY00005143 NCI-2023-00104, STUDY00005143 | Ph 2 | recruiting | Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology |
| NCT05524545 | ASPEN-07 | Ph 1 | completed | A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07) |
| NCT04223856 EV-302 results posted | SGN22E-003 2019-004542-15, MK-3475-A39 | Ph 3 | active not recruiting | Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer |
| NCT05915351 | STUDY00150104 | Ph 2 | active not recruiting | Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC) |
| NCT06493552 | B2-001 | Ph 2, Ph 3 | recruiting | Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors |
| NCT06904573 IMPROVE | 2024-FXY-297 | Ph 2 | recruiting | Probiotics in Advanced Urothelial Carcinoma |
Showing 50 of 55 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PADCEV FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment