Drugs / Enfortumab Vedotin
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | PADCEV | — | 2021-07-09 – 2026-07-10 | fda.gov ↗ |
| Approved | EU (EMA) | Padcev | — | 2022-04-13 | europa.eu ↗ |
| Approved | US (FDA) | PADCEV | — | 2019-12-18 | fda.gov ↗ |
Trials 64 · started per year
today
US approved 2019
EU approved 2022
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07217496 | Feb 2026 → May 2027 | urothelial carcinoma | Vadim S Koshkin | Withdrawn | No outcome recorded |
| Phase 1 | NCT05614739 | Jan 2023 → Jun 2027 expected | metastatic neoplasm, ureter neoplasm, urinary bladder neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05524545 | Nov 2022 → Jun 2025 | urinary bladder cancer, urothelial carcinoma | ALX Oncology Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04963153 | Jul 2022 → Dec 2026 expected | ureter cancer, urethra cancer, urothelial carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05014139 | Dec 2021 → Sep 2025 | in situ carcinoma, non-invasive bladder urothelial carcinoma | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT04878029 | Jul 2021 → Nov 2027 expected | infiltrating bladder urothelial carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT03070990 | Apr 2017 → Feb 2019 | urothelial carcinoma | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02091999 | May 2014 → Dec 2022 | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01409135 | Jul 2011 → Apr 2015 | neoplasm | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07667335 | Dec 2026 → Jul 2029 expected | infiltrating urothelial carcinoma, urinary bladder carcinoma, urothelial carcinoma | Fred Hutchinson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07421700 | Mar 2026 → Dec 2027 expected | urothelial carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06470282 | Mar 2025 → Jan 2028 expected | urinary bladder carcinoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06434350 | Oct 2024 → Sep 2027 expected | urinary bladder cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06394570 | Sep 2024 → Jul 2026 overdue | urinary bladder cancer | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06483334 | Jul 2024 → Mar 2028 expected | urothelial carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06305767 | Mar 2024 → Apr 2027 expected | urinary bladder cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04724018 | May 2021 → Feb 2027 expected | renal pelvis/ureter urothelial carcinoma, urinary bladder cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03869190 | Jun 2019 → Oct 2025 | urinary bladder cancer, urothelial carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03288545 | Oct 2017 → Feb 2026 | renal pelvis neoplasm, ureter neoplasm, urethra neoplasm, urinary bladder neoplasm +1 | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded |
| Phase 236 trials | ||||||
| Phase 2 | NCT07643519 | Oct 2026 → Feb 2029 expected | urothelial carcinoma | University of Florida | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07663747 | Sep 2026 → Apr 2031 expected | urinary bladder cancer | The Netherlands Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07139977 | Jul 2026 → Nov 2027 expected | endometrial cancer | William Bradley | Recruiting | No outcome recorded |
| Phase 2 | NCT07690878 | Jul 2026 → Oct 2027 expected | urinary bladder cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07475806 | Mar 2026 → Nov 2027 expected | urinary bladder carcinoma | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07221942 | Jan 2026 → Sep 2028 expected | urothelial carcinoma | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06041503 | Jan 2026 → Oct 2027 expected | bladder adenocarcinoma, bladder squamous cell carcinoma, testicular germ cell tumor | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07183319 | Jan 2026 → Mar 2028 expected | urothelial carcinoma | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 2 | NCT07110038 | Dec 2025 → May 2029 expected | squamous cell carcinoma of penis | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT07347314 | Nov 2025 → Sep 2028 expected | small intestine adenocarcinoma | National Cancer Center, Japan | Recruiting | No outcome recorded |
| Phase 2 | NCT07087860 | Aug 2025 → Aug 2028 expected | renal pelvis/ureter urothelial carcinoma, urinary bladder carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06356155 | Jul 2025 → Mar 2028 expected | urothelial carcinoma | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06906822 | Jun 2025 → Jun 2027 expected | melanoma | Spanish Melanoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06302569 | May 2025 → Oct 2027 expected | collecting duct carcinoma, kidney medullary carcinoma | Giuseppe Procopio | Recruiting | No outcome recorded |
| Phase 2 | NCT07647289 | Apr 2025 → Apr 2027 expected | infiltrating bladder urothelial carcinoma | Peking University Third Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06809140 | Apr 2025 → Nov 2027 expected | infiltrating bladder urothelial carcinoma | Matthew Galsky | Recruiting | No outcome recorded |
| Phase 2 | NCT06553885 | Apr 2025 → Sep 2029 expected | colorectal cancer, hepatocellular carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06891560 | Mar 2025 → Mar 2027 expected | adenoid cystic carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06311214 | Mar 2025 → Mar 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05656235 | Nov 2024 → Jun 2028 expected | bladder transitional cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT05775471 | Jun 2024 → Jan 2027 expected | renal pelvis/ureter urothelial carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06104618 | Dec 2023 → Jun 2028 expected | squamous cell carcinoma of penis | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05879653 | Oct 2023 → Sep 2025 overdue | urinary bladder cancer | Kyoto University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05756569 | Sep 2023 → Dec 2026 expected | bladder squamous cell carcinoma, bladder urachal adenocarcinoma, malignant renal pelvis neoplasm, ureter cancer +1 | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05915351 | Jun 2023 → Jun 2025 overdue | pancreatic ductal adenocarcinoma | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05923190 | Jun 2023 → Jul 2028 expected | urothelial carcinoma | Fox Chase Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05868265 | Jun 2023 → Jun 2027 expected | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04754191 | Jun 2022 → Apr 2025 overdue | castration-resistant prostate carcinoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05239624 | Jun 2022 → Jun 2027 expected | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT04995419 | Jul 2021 → May 2022 | urothelial carcinoma | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT04225117 | Mar 2020 → Feb 2025 overdue | — | Astellas Pharma Global Development, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03606174 | Sep 2018 → Aug 2022 | ureter transitional cell carcinoma, urethra transitional cell carcinoma, urinary bladder cancer | Mirati Therapeutics Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03547973 | Aug 2018 → Apr 2030 expected | urothelial carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT03219333 | Oct 2017 → Oct 2020 | renal pelvis neoplasm, ureter neoplasm, urethra neoplasm, urinary bladder neoplasm +1 | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07566156 | May 2026 → Mar 2030 expected | urinary bladder neoplasm, urothelial carcinoma | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04960709 | Aug 2021 → Mar 2026 overdue | urinary bladder carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04700124 | Apr 2021 → Oct 2025 overdue | urinary bladder cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04223856 | Mar 2020 → Aug 2023 overdue | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03924895 | Jul 2019 → Jun 2025 overdue | urinary bladder carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03474107 | Jun 2018 → Jul 2020 | ureter cancer, urinary bladder cancer, urothelial carcinoma | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06862219 | Jun 2025 → Dec 2026 expected | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT06764095 | Jan 2025 → Dec 2034 expected | bladder transitional cell carcinoma, renal pelvis/ureter urothelial carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04136808 | — | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07484022 Background | Jun 2026 → Jun 2027 expected | urothelial carcinoma | Generate Biomedicines | Recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07232602 Background | Feb 2026 → Jul 2031 expected | urinary bladder cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07287995 Background | Feb 2026 → Jun 2029 expected | — | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07157956 Background | Sep 2025 → Aug 2028 expected | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07662863 Comparator | Jul 2026 → Dec 2028 expected | peripheral neuropathy, urinary bladder cancer, urothelial carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07374549 Comparator | Jun 2026 → Jun 2028 expected | urothelial carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06904573 Background | Jan 2025 → Jan 2027 expected | urothelial carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06493552 Comparator | Mar 2025 → Sep 2029 expected | urinary bladder carcinoma, urothelial carcinoma | Vasgene Therapeutics, Inc | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04887870 Background | Jun 2021 → Apr 2025 | cancer of unknown primary site | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07346053 Comparator | May 2026 → Dec 2030 expected | urinary bladder cancer | Guliz Ozgun | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07218380 Background | Dec 2025 → Oct 2029 expected | metastatic malignant neoplasm, transitional cell carcinoma, urinary bladder cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07629700 Background | Sep 2026 → Sep 2027 expected | peripheral neuropathy, urothelial carcinoma | University of Florence | Not yet recruiting | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Pfizer | U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility pfizer.com ↗ |
| 2026-04-20 | Pfizer | U.S. FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility pfizer.com ↗ |
| 2026-02-27 | Pfizer | PADCEV™ + Keytruda® Cuts Risk of Recurrence or Death by Nearly 50% in Cisplatin-Eligible Muscle-Invasive Bladder Cancer pfizer.com ↗ |
| 2025-12-17 | Pfizer | PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility pfizer.com ↗ |
| 2025-11-21 | Pfizer | U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer pfizer.com ↗ |
| 2025-10-18 | Pfizer | PADCEV™ Plus KEYTRUDA™, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60% and the Risk of Death by 50% for Certain Patients with Bladder Cancer pfizer.com ↗ |
| 2025-08-12 | Pfizer | PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery pfizer.com ↗ |
| 2025-02-10 | Pfizer | Pfizer and Astellas’ PADCEV® (enfortumab vedotin-ejfv) plus KEYTRUDA® (pembrolizumab) Shows Long-Term Efficacy in First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC) pfizer.com ↗ |
| 2024-01-26 | Pfizer | European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer pfizer.com ↗ |
| 2023-12-15 | Pfizer | PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer pfizer.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 78 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enfortumab Vedotin | “FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab...” NCT07218380 ↗72“Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab...” NCT07690878 ↗ “EV (Enfortumab Vedotin): 1.25 mg/kg administered intravenously on Days 1, 8, and 15 of every 4 weeks.” NCT07662863 ↗ “Arm A: MK-3120 + Enfortumab Vedotin (EV) + Pembrolizumab” NCT07232602 ↗ |
| Known as | ASG-22CE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05879653 ↗ |
| Known as | ASG-22ME | “Hybridoma (AGS-22M6E) and CHO (ASG-22CE) versions of enfortumab vedotin (also known as ASG-22ME) ADC were able to bind to cell surface-expressed nectin-4 with high affinity and...” PMID 27013195 ↗ Mar 2016 |
| Known as | enfortumab | “Enfortumab vedotin (enfortumab) is an investigational ADC” NCT03606174 ↗ |
| Known as | Enfortumab vedotin-ejfv | “Enfortumab vedotin-ejfv (EV)” NCT04724018 ↗ |
| Known as | Padcev | “CVL006（B006 Injection）、Enfortumab Vedotin（Padcev）” NCT07157956 ↗ |
| Action | Deplete | “Enfortumab attaches to nectin-4 tumor cells in a targeted way and delivers vedotin to kill them.” NCT04878029 ↗ |
| Modality | Monoclonal antibody | “AGS-22M6E and ASG-22CE are fully human monoclonal antibody conjugated to a cytotoxic agent monomethyl auristatin E (MMAE)” NCT01409135 ↗ |
| Route | Intravenous | “IV Infusion” NCT01409135 ↗ |
| Target | NECTIN4 | “a novel antibody-drug conjugate directed against Nectin-4” PMID 40819431 ↗ Jul 2025 |