Enfortumab vedotin
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2019
- First approval year
- 2019
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Enfortumab vedotin
- padcev
- Padcev
- ags 22ce
- ags 22m6e
- ags 22me
- ags 22mse
- AGS-22CE
- AGS-22M6E
- AGS-22ME
- AGS-22MSE
- asg 22ce
- asg 22me
- Asg-22ce
- ASG-22CE
- ASG-22ME
- enfortumab vedotin
- Enfortumab vedotin
- Enfortumab Vedotin
- enfortumab vedotin (EV)
- Enfortumab vedotin (EV)
- Enfortumab Vedotin (EV)
- ENFORTUMAB VEDOTIN (fully human monoclonal antibody conjugated to a cytotoxic agent monomethyl auristatin E (MMAE) targeting nectin-4)
- enfortumab vedotin [INN]
- ENFORTUMAB VEDOTIN [JAN]
- ENFORTUMAB VEDOTIN [MI]
- ENFORTUMAB VEDOTIN [USAN]
- Enfortumab vedotin [WHO-DD]
And 17 more, listed on the interactive page.
- ATC classification codes
- L01FX13
Sources for recorded values
- CAS registry numbers
- 1346452-25-2
- ChEMBL ID
- CHEMBL3301589
- FDA ingredient codes (UNII)
- DLE8519RWM
- 2268306
- 2277607
- Applicant
- ASTELLAS
- Approval date
- 18 Dec 2019
- Application number
- BLA761137
- Status
- Authorised
- Status date
- 13 Apr 2022
- Authorisation date
- 13 Apr 2022
- Approved indications
- Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. Unresectable or metastatic urothelial cancer Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. Locally advanced or metastatic urothelial cancer Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor‑1 or programmed death‑ligand 1 inhibitor (see section 5.1).
- Product number
- EMEA/H/C/005392
- Authorisation holder
- Astellas Pharma Europe B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Transitional Cell
- Urologic Neoplasms
European medicines record
- Patents
- 0
- Designations
- 7
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- enfortumab vedotin
- Type
- Antibody
- Drug name stem
- -dotin; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Nectin-4 binding agent
- Action type
- BINDING_AGENT
- Target
- Nectin-4
- Protein identifier
- Q96NY8
- Action
- Binding
- Action type
- Binding
- Target
- nectin cell adhesion molecule 4
- Gene symbol
- NECTIN4
- Protein identifier
- Q96NY8
- Primary target
- Yes
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9H4B7
- Mechanism
- Nectin-4 binding agent
- Action type
- BINDING AGENT
- Target
- Nectin-4
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008528
- Subject identifier
- D001749
- Condition
- Carcinoma, Transitional Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000601
- Subject identifier
- D002295
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001187
- Subject identifier
- D001749
- Condition
- Urologic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004180
- Subject identifier
- D014571
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004986
- Subject identifier
- D001749
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Carcinoma, Pancreatic Ductal
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005184
- Subject identifier
- D021441
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
- Condition identifier
- EFO_0000231
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008528
- Condition identifier
- EFO_1000601
- Condition identifier
- MONDO_0000521
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001187
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002447
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003198
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004180
- Condition identifier
- MONDO_0004192
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004971
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004986
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004992
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005220
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005627
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006047
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006474
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007254
- Highest recorded phase
- 1
And 10 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Event
- blister
- Reports
- 26
- Reporting signal score
- 34.7438
- Event
- decreased appetite
- Reports
- 38
- Reporting signal score
- 21.8572
- Event
- dermatitis bullous
- Reports
- 15
- Reporting signal score
- 31.2125
- Event
- drug hypersensitivity
- Reports
- 1
- Reporting signal score
- 13.314
- Event
- extravasation
- Reports
- 10
- Reporting signal score
- 20.2045
- Event
- headache
- Reports
- 3
- Reporting signal score
- 21.7063
- Event
- hepatitis
- Reports
- 14
- Reporting signal score
- 13.9864
- Event
- hyperglycaemia
- Reports
- 29
- Reporting signal score
- 44.7308
- Event
- immune-mediated enterocolitis
- Reports
- 5
- Reporting signal score
- 13.6599
- Event
- infusion site extravasation
- Reports
- 13
- Reporting signal score
- 29.7769
- Event
- lacrimation increased
- Reports
- 12
- Reporting signal score
- 16.8794
- Event
- malignant neoplasm progression
- Reports
- 79
- Reporting signal score
- 154.82
- Event
- neuropathy peripheral
- Reports
- 130
- Reporting signal score
- 270.352
- Event
- neutropenia
- Reports
- 35
- Reporting signal score
- 16.2057
- Event
- ocular toxicity
- Reports
- 5
- Reporting signal score
- 16.3316
- Event
- pleurisy bacterial
- Reports
- 2
- Reporting signal score
- 13.6412
- Event
- pneumonitis
- Reports
- 16
- Reporting signal score
- 19.8268
- Event
- pruritus
- Reports
- 41
- Reporting signal score
- 14.6156
- Event
- pulmonary toxicity
- Reports
- 15
- Reporting signal score
- 38.0627
- Event
- rash
- Reports
- 178
- Reporting signal score
- 203.675
- Event
- rash erythematous
- Reports
- 20
- Reporting signal score
- 24.7923
- Event
- rash pruritic
- Reports
- 19
- Reporting signal score
- 18.9042
- Event
- rash vesicular
- Reports
- 7
- Reporting signal score
- 15.5476
- Event
- skin disorder
- Reports
- 14
- Reporting signal score
- 18.6145
- Event
- skin exfoliation
- Reports
- 18
- Reporting signal score
- 21.2397
And 7 more, listed on the interactive page.
- NCT01409135
- NCT02091999
- NCT03070990
- NCT04887870
- NCT04995419
- NCT06434350
- NCT04225117
- NCT06311214
- NCT03869190
- NCT04878029
- NCT05239624
- NCT05868265
- NCT05923190
- NCT06356155
- NCT06483334
- NCT03924895
- NCT04700124
- NCT04960709
- NCT05879653
- NCT06394570
- NCT04754191
- NCT05915351
- NCT06470282
- Dose
- 1.25 mg/kg (up to a maximum of 125 mg)
- Route
- Intravenous
- How often
- Every 21 days or until disease progression or unacceptable toxicity
- Administer as an infusion over 30 minutes
- Do not administer as an intravenous push or bolus
- Do not mix with other medicinal products
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYNMNWVRQAPGKGLEWVSYISSSSSTIYYADSVKGRFTISRDNAKNSLSLQMNSLRDEDTAVYYCARAYYYGMDVWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- DIQMTQSPSSVSASVGDRVTITCRASQGISGWLAWYQQKPGKAPKFLIYAASTLQSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPPTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 51144-020
- 51144-030
Related records
Trials (75)
- A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
- A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
- A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
- A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
- 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)
- A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
- A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
- A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
- A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
- A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
- A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4
- A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
- A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
- A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4
- 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
- A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
- A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
- A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
- A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
- An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
Approved for (4)
- Benign urinary system neoplasm
- Cancer
- Neoplasm
- Transitional cell carcinoma
In development for (8)
- Adenoid cystic carcinoma Phase 2
- Endometrial cancer Phase 2
- Exocrine pancreatic carcinoma Phase 2
- Pancreatic ductal adenocarcinoma Phase 2
- Prostate cancer Phase 2
- Urinary bladder cancer Phase 3
- Urinary bladder carcinoma Phase 3
- Urothelial carcinoma Phase 3
Targets (16)
- NECTIN4 Nectin-4 binding agent
- TUBA1A Tubulin inhibitor
- TUBA1B Tubulin inhibitor
- TUBA1C Tubulin inhibitor
- TUBA3C Tubulin inhibitor
- TUBA3E Tubulin inhibitor
- TUBA4A Tubulin inhibitor
- TUBB Tubulin inhibitor
- TUBB1 Tubulin inhibitor
- TUBB2A Tubulin inhibitor
- TUBB2B Tubulin inhibitor
- TUBB3 Tubulin inhibitor
- TUBB4A Tubulin inhibitor
- TUBB4B Tubulin inhibitor
- TUBB6 Tubulin inhibitor
- TUBB8 Tubulin inhibitor