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.

health-canada-dpdRegulatory12 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as PADCEV (DIN 02521911) under ATC L01FX13 ENFORTUMAB VEDOTIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 10, 2023	health-canada-dpd
CA Health Canada	—	Marketed in Canada as PADCEV (DIN 02521903) under ATC L01FX13 ENFORTUMAB VEDOTIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 20, 2021	health-canada-dpd
EU EMA	Malignant Bladder Neoplasm	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).

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.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

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.

clinicaltrialsPublishedShowing 1–50 of 72 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07421700	Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer	recruiting	Phase 1 / Phase 2	132	PfizerINDUSTRY	6	Sep 28, 2026	clinicaltrials
NCT07217496	N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer	not yet recruiting	Phase 1

Molecule

Record

Kind: Adc
Mechanism: Nectin-4 binding agent; Tubulin inhibitor
Targets: 16 genes
UNII: DLE8519RWM
Aliases: AGS-22CE, AGS-22M6E, AGS 22ME, AGS-22ME, AGS-22MSE, Anti-Nectin 4 ADC ASG-22CE, Anti-nectin-4 Monoclonal Antibody-Drug Conjugate AGS-22M6E, ASG 22CE, ASG22CE, ASG-22ME, Enfortumab Vedotin, Enfortumab vedotina, Enfortumab vedotine, Enfortumab Vedotin-ejfv, Padcev, PADCEV EJFV

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (6)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FX13	ENFORTUMAB VEDOTIN
DIN (Health Canada)	02521903	PADCEV