Padcev

(Enfortumab vedotin)

ApprovedAntibody–drug conjugate

Enfortumab vedotin is used to treat advanced bladder cancer (urothelial carcinoma) in patients who have already received other treatments. It works by delivering a cancer-killing toxin directly to cancer cells.[2] Padcev is currently approved and in use across 22 indications[4].[1]

Padcev is one of 341 antibody-drug conjugate programs targeting Adenoid Cystic Carcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

340

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Adenoid Cystic CarcinomaRecruiting

AdenocarcinomaRecruiting

Benign Urinary System NeoplasmUnknown

Pancreatic CancerActive, not recruiting

Prostate CancerActive, not recruiting

Bladder CancerActive, not recruiting

Endometrial CancerRecruiting

Urinary Bladder NeoplasmsTerminated

Metastatic Urothelial CarcinomaRecruiting

Renal Pelvis and Ureter Urothelial CarcinomaRecruiting

Adenoid Cystic CarcinomaPhase 2

Recruiting

AdenocarcinomaPhase 2

Recruiting

Benign Urinary System NeoplasmPreclinical

Unknown

Pancreatic CancerPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Bladder CancerPhase 3

Active, not recruiting

Endometrial CancerPhase 2

Recruiting

Urinary Bladder NeoplasmsPhase 1

Terminated

Metastatic Urothelial CarcinomaApproved

Recruiting

Renal Pelvis and Ureter Urothelial CarcinomaPhase 2

Recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Padcev

Pfizer

Approved

1 2

Androgen Deprivation Therapy

Johnson & Johnson

Phase 3

48 3

Orgovyx

Sumitomo Pharma America, Inc.

Phase 3

12 4

Acetylsalicylic Acid

Bayer

Phase 3

2 5

Antibiotic

Pfizer

Phase 3

1 6

Xaluritamig

Amgen

Phase 3

4 7

Radium-223

Bayer

Phase 3

6 8

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Phase 3

1 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Locally Advanced Bladder Urothelial Carcinoma

NCT04963153

Phase 1Recruiting

Metastatic Urothelial Cancer

NCT04878029

Q1 2027

Phase 2Active, not recruiting

Prostate Cancer

NCT04754191

Phase 2Recruiting

Adenoid Cystic Carcinoma

NCT06891560

Phase 2Active, not recruiting

Locally Advanced or Metastatic Malignant Solid Tumors

NCT04225117

Q2 2027

Phase 1Recruiting

Urinary Bladder Neoplasms

NCT05614739

Clinical

Trials by Indication[1]

Urothelial Carcinoma13 trials

Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Active, not recruiting·FFox Chase Cancer Center·Phase 2·NCT05923190·60 enrolled

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)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06483334·38 enrolled

Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma

Recruiting·FFox Chase Cancer Center·Phase 2·NCT07221942·97 enrolled

Show 10 more trials

A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Completed· Astellas logo

Astellas·Phase 1·NCT03070990·19 enrolled

A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

Completed·AALX Oncology Inc.·Phase 1·NCT05524545·36 enrolled

Probiotics in Advanced Urothelial Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT06904573·222 enrolled

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 2·NCT07374549·100 enrolled

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

Terminated·MMirati Therapeutics Inc.·Phase 2·NCT03606174·260 enrolled

An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Approved for marketing· Astellas logo

Astellas··NCT04136808

Enfortumab Vedotin in Combination With Pembrolizumab for Locally Advanced and/or Node Positive Urothelial Carcinoma Prior to Surgery (EV-ECLIPSE)

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05239624·27 enrolled

Neoadjuvant Enfortumab Vedotin in High-Grade Urothelial Carcinoma of the Upper Urinary Tract (Including Ureter and Renal Pelvis)

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05868265·9 enrolled

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Terminated· Roche logo

Roche·Preclinical·NCT03869190·272 enrolled

A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer (NEPTUNE)

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT06356155·32 enrolled

Bladder Cancer9 trials

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Completed· Astellas logo

Astellas·Phase 2·NCT03219333·219 enrolled

Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers

Recruiting·MMayo Clinic·Phase 2·NCT07087860·70 enrolled

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06305767·230 enrolled

Show 6 more trials

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04960709·712 enrolled

Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06434350·41 enrolled

GU-254: A Phase II Trial of Risk-Enabled Therapy After Initiating Neoadjuvant Enfortumab Vedotin/Pembrolizumab for Bladder Cancer (RETAIN-3)

Recruiting·FFox Chase Cancer Center·Phase 2·NCT07908979·70 enrolled

EV-PRIME: Phase Ib/II Study of Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy as a Bladder-Sparing Trimodality Therapy in Muscle Invasive Bladder Cancer

Recruiting·UUniversity of California, San Francisco·Preclinical·NCT06470282·47 enrolled

Stereotactic Treatment With neoAdjuvant Radiotherapy and Enfortumab Vedotin: a Phase I/II Study With Safety Lead-In for Localized Bladder Cancer (STAR-EV)

Recruiting·UUniversity of Texas Southwestern Medical Center·Preclinical·NCT06394570·19 enrolled

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04700124·808 enrolled

Urothelial Cancer6 trials

Renal Retention in High Grade Upper Tract Urothelial Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05656235·20 enrolled

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Terminated· Astellas logo

Astellas·Phase 1/2·NCT03288545·348 enrolled

A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY

Recruiting· Astellas logo

Astellas·Phase 3·NCT07566156·390 enrolled

Show 3 more trials

A Phase 1/2, Multicenter, Master Protocol Trial to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) in Participants With Solid Tumors (TROPION-PanTumor04)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT07890714·268 enrolled

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Recruiting· Astellas logo

Astellas··NCT06011954·228 enrolled

AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

Recruiting· Pfizer logo

Pfizer·Preclinical·NCT07421700·132 enrolled

Metastatic Urothelial Cancer6 trials

Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

Recruiting·EEmory University·Phase 1·NCT04878029·32 enrolled

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Completed· Astellas logo

Astellas·Phase 3·NCT03474107·608 enrolled

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT04223856·886 enrolled

Show 3 more trials

A Single-arm, Open-label, Multi-center Phase 2 Study of Enfortumab Vedotin (ASG-22CE) in Chinese Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and PD 1/PD-L1 Inhibitor Therapy (EV-203)

Completed· Astellas logo

Astellas·Phase 2·NCT04995419·40 enrolled

A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT03547973·502 enrolled

A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Completed· Astellas logo

Astellas·Phase 1·NCT02091999·213 enrolled

Locally Advanced Bladder Urothelial Carcinoma3 trials

A Phase Ib/II Study to Evaluate the Safety and Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Combination With Quemliclustat in Unresectable Locally Advanced and Metastatic Urothelial Carcinoma

Recruiting·FFred Hutchinson Cancer Center·Preclinical·NCT07667335·27 enrolled

CAST-AI: Cystectomy After Systemic Therapy With ADC and Immunotherapy

Recruiting·MMayo Clinic·Approved·NCT06764095·75 enrolled

Phase Ib Trial of Erdafitinib Combined With Enfortumab Vedotin Following Prior Therapies for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04963153·24 enrolled

28 more indications

Metastatic Urothelial Carcinoma3 trials

Open-Label, Single-Arm, Phase 1b Clinical Trial of NAI Plus Pembrolizumab With Short Course of Enfortumab Vedotin in Treatment-Naïve Participants With Metastatic Urothelial Carcinoma

Not yet recruiting·VVadim S Koshkin·Phase 1·NCT07217496·18 enrolled

A Randomized Phase 2/3 Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)

Recruiting·SSummit Therapeutics·Preclinical·NCT07815665·800 enrolled

A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer

Recruiting· Astellas logo

Astellas·Approved·NCT06862219·100 enrolled

Adenocarcinoma2 trials

Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy

Recruiting·NNational Cancer Center, Japan·Phase 2·NCT07347314·27 enrolled

A Phase II Multicenter Study of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06041503·68 enrolled

Urinary Bladder Neoplasms2 trials

FORAGER-1: A Phase 1, Open-Label, Multicenter Study of Vepugratinib (LY3866288; LOXO-435) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer and Muscle Invasive Bladder Cancer With FGFR3 Alterations

Recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05614739·677 enrolled

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Terminated· Astellas logo

Astellas·Phase 1·NCT05014139·37 enrolled

Locally Advanced or Metastatic Malignant Solid Tumors2 trials

A Phase 1b/2 Study of ASP2998 as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors

Recruiting· Astellas logo

Astellas·Preclinical·NCT07287995·428 enrolled

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Active, not recruiting· Astellas logo

Astellas·Phase 2·NCT04225117·329 enrolled

Metastatic1 trial

Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06553885·40 enrolled

Solid Tumors1 trial

Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors

Recruiting·VVasgene Therapeutics, Inc·Phase 2/3·NCT06493552·700 enrolled

Observational Study1 trial

Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Recruiting·SSpanish Oncology Genito-Urinary Group··NCT06724159·500 enrolled

Salivary Gland Carcinoma1 trial

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

Recruiting·PPeking Union Medical College·Phase 2·NCT06145308·39 enrolled

Prostate Cancer1 trial

Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting·UUniversity of Utah·Phase 2·NCT04754191·34 enrolled

Squamous Cell Carcinoma1 trial

Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis

Recruiting·MMayo Clinic·Phase 2·NCT06104618·28 enrolled

Pancreatic Cancer1 trial

Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)

Active, not recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT05915351·28 enrolled

Muscle-Invasive Bladder Cancer1 trial

An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)

Recruiting· Astellas logo

Astellas·Phase 2·NCT07475806·240 enrolled

Advanced Malignant Solid Neoplasm1 trial

Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06311214·500 enrolled

Endometrial Cancer1 trial

Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma

Recruiting·WWilliam Bradley·Phase 2·NCT07139977·12 enrolled

Penile Squamous Cell Carcinoma1 trial

DEPECA-1 - DEfeating PEnile Cancer 1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT07110038·25 enrolled

Advanced Urothelial Cancer1 trial

A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GB-4362 Administered With Enfortumab Vedotin and Pembrolizumab in Participants With Advanced Urothelial Cancer

Recruiting·GGenerate Biomedicines·Phase 1·NCT07484022·37 enrolled

Differentiated Thyroid Gland Carcinoma1 trial

Phase II Multi-Center Open-Label Trial of Enfortumab Vedotin Treatment for Patients With Aggressive Radioiodine Refractory Differentiated Thyroid Cancer, Aggressive Poorly Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer and NUT Carcinoma

Not yet recruiting·NNorthwestern University·Phase 2·NCT07863765·56 enrolled

Adenoid Cystic Carcinoma1 trial

Phase II Trial of Enfortumab Vedotin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06891560·34 enrolled

Melanoma1 trial

A Phase II, Open-label, Multicenter, Non-Randomized Study of the Efficacy and Safety of Enfortumab Vetodin in Combination With Pembrolizumab Previously Treated Advanced Melanoma

Active, not recruiting·GGrupo Español Multidisciplinar de Melanoma·Phase 2·NCT06906822·60 enrolled

Metastatic Pancreatic Adenocarcinoma1 trial

An Umbrella Clinical Trial of Antibody/Peptide-Drug Conjugates Matched by Mass Spectrometry-Based Absolute Quantitation of Proteins in Locally Advanced or Metastatic Pancreatic or Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT07825753·225 enrolled

Bladder Urothelial Carcinoma1 trial

PRESERVE: A Phase 2 Study Evaluating Bladder Preservation With Enfortumab Vedotin Plus Pembrolizumab in Patients With Muscle-Invasive Urothelial Cancer

Not yet recruiting·UUniversity of Utah·Phase 2·NCT07822373·25 enrolled

Muscle Invasive Bladder Urothelial Carcinoma1 trial

Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder

Recruiting·MMatthew Galsky·Phase 2·NCT06809140·75 enrolled

Bladder Squamous Cell Carcinoma1 trial

Phase II Single-Arm Study of Enfortumab Vedotin (EV) Plus Pembrolizumab in the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

Recruiting·EEmory University·Phase 2·NCT05756569·25 enrolled

Transitional Cell Carcinoma1 trial

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07720284·915 enrolled

Renal Pelvis and Ureter Urothelial Carcinoma1 trial

Neoadjuvant Combination Pembrolizumab / Enfortumab Vedotin With Adjuvant Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Carcinoma

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT05775471·21 enrolled

Urinary Bladder Cancer, Muscle-invasive1 trial

A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT03924895·595 enrolled

Urinary Bladder Cancer1 trial

A Phase 2 Study to Assess Efficacy of Induction Enfortumab Vedotin Plus Pembrolizumab Using a Response-adapted Approach to Spare the Bladder: FIDELIO

Not yet recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT07663747·56 enrolled

Unspecified1 trial

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 18, 2019

PADCEV

NDA BLA761137

Dec 18, 2019

PADCEV EJFV

BLA BLA761137

Mar 22, 2021

PADCEV

NDA BLA761137

Jul 9, 2021

PADCEV

NDA BLA761137

Jul 9, 2021

PADCEV

NDA BLA761137

Oct 28, 2022

PADCEV

NDA BLA761137

Apr 3, 2023

PADCEV

NDA BLA761137

Apr 3, 2023

PADCEV

NDA BLA761137

Apr 18, 2023

PADCEV

NDA BLA761137

Dec 15, 2023

PADCEV

NDA BLA761137

Dec 15, 2023

PADCEV

NDA BLA761137

Feb 27, 2025

PADCEV

NDA BLA761137

Nov 21, 2025

PADCEV

NDA BLA761137

Jul 10, 2026

PADCEV

NDA BLA761137

Sources

References

[1]
ClinicalTrials.gov — 70 trial records for Enfortumab vedotin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Padcev drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Enfortumab vedotin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Enfortumab vedotin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761137). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Enfortumab vedotin. U.S. National Library of Medicine.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Nectin-4 ADC[3]
Modality: Antibody–drug conjugate[3]
Highest Phase: Approved[1]
Company: Pfizer

Key Publications[6]

Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer: EV-302

N Engl J MedDec 14, 2023DOI: 10.1056/NEJMoa2312117

Padcev

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Urothelial Carcinoma13 trials

Bladder Cancer9 trials

Urothelial Cancer6 trials

Metastatic Urothelial Cancer6 trials

Locally Advanced Bladder Urothelial Carcinoma3 trials

Metastatic Urothelial Carcinoma3 trials

Adenocarcinoma2 trials

Urinary Bladder Neoplasms2 trials

Locally Advanced or Metastatic Malignant Solid Tumors2 trials

Metastatic1 trial

Solid Tumors1 trial

Observational Study1 trial

Salivary Gland Carcinoma1 trial

Prostate Cancer1 trial

Squamous Cell Carcinoma1 trial

Pancreatic Cancer1 trial

Muscle-Invasive Bladder Cancer1 trial

Advanced Malignant Solid Neoplasm1 trial

Endometrial Cancer1 trial

Penile Squamous Cell Carcinoma1 trial

Advanced Urothelial Cancer1 trial

Differentiated Thyroid Gland Carcinoma1 trial

Adenoid Cystic Carcinoma1 trial

Melanoma1 trial

Metastatic Pancreatic Adenocarcinoma1 trial

Bladder Urothelial Carcinoma1 trial

Muscle Invasive Bladder Urothelial Carcinoma1 trial

Bladder Squamous Cell Carcinoma1 trial

Transitional Cell Carcinoma1 trial

Renal Pelvis and Ureter Urothelial Carcinoma1 trial

Urinary Bladder Cancer, Muscle-invasive1 trial

Urinary Bladder Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News