Enfortumab vedotin
Approved · FDA / EMARecent clinical, regulatory, research and industry developments relating to this drug.
Indication expansion: ENFORTUMAB VEDOTIN (BLA761137)
Indication expansion: ENFORTUMAB VEDOTIN (BLA761137)
Label change: ENFORTUMAB VEDOTIN (BLA761137)
Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.
Indication expansion: ENFORTUMAB VEDOTIN (BLA761137)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is… Show full indicationShow less
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).
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology4
- Annals of oncology : official journal of the European Society for Medical Oncology2
- Clinical cancer research : an official journal of the American Association for Cancer Research2
- The New England journal of medicine2
- Petrylak DP5
- Rosenberg JE4
- Castellano D3
- Flaig TW3
- Loriot Y3
- Powles T3
- Sonpavde GP3
- Srinivas S3
- Memorial Sloan Kettering Cancer Center3
- University of Colorado Comprehensive Cancer Center3
- Yale Cancer Center3
- Bavarian Center for Cancer Research (Bayerisches Zentrum für Krebsforschung2
- Center for Integrated Oncology Aachen/Bonn/Cologne/Düsseldorf (CIO-ABCD)2
- Clinic for Internal Medicine (Tumor Research) and Clinic for Urology2
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Acts on the same molecular target as Enfortumab vedotin, with 3 overlapping disease areas.
Studied across 4 of the same disease areas as Enfortumab vedotin in the shared literature.
Studied across 4 of the same disease areas as Enfortumab vedotin in the shared literature.
Studied across 4 of the same disease areas as Enfortumab vedotin in the shared literature.
Studied across 3 of the same disease areas as Enfortumab vedotin in the shared literature.
Studied across 3 of the same disease areas as Enfortumab vedotin in the shared literature.
Studied across 3 of the same disease areas as Enfortumab vedotin in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.