Drugs / ENFORTUMAB VEDOTIN
last change 24 days ago re-read 9 days ago

ENFORTUMAB VEDOTIN

Monoclonal antibody targets NECTIN4

Developed for
neoplasm
Investigated by
Agensys, Inc. · Astellas Pharma Inc · Seagen Inc.

Trials 1

2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT01409135 Jul 2011 → Apr 2015 neoplasm Astellas Pharma Inc Completed No outcome recorded

Press releases naming this drug 93 releases

DateIssuerRelease
2026-09-17 Astellas Pharma Inc PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Adults with Resectable Muscle-Invasive Bladder Cancer astellas.com ↗
2026-07-12 Astellas Pharma Inc U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility astellas.com ↗
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 ↗
2026-07-10 Merck Sharp & Dohme LLC FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC) merck.com ↗
2026-07-06 Astellas Pharma Inc China’s National Medical Products Administration Accepts Biologics License Application for PADCEV™ (enfortumab vedotin) plus Keytruda® (pembrolizumab) in Muscle-Invasive Bladder Cancer astellas.com ↗
2026-06-24 Merck Sharp & Dohme LLC European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First PD-1 Inhibitor Plus Antibody-Drug Conjugate Regimen for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer merck.com ↗
2026-06-23 Astellas Pharma Inc European Commission Approves PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) as the First and Only Approved Perioperative Treatment Option for Cisplatin-Ineligible Patients with Resectable Muscle-Invasive Bladder Cancer astellas.com ↗
2026-05-22 Merck Sharp & Dohme LLC Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer merck.com ↗
2026-05-21 Astellas Pharma Inc PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Patients with Resectable Muscle-Invasive Bladder Cancer who are Ineligible for Cisplatin-Based Chemotherapy astellas.com ↗
2026-05-14 Astellas Pharma Inc Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin) plus Keytruda® (pembrolizumab) in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer astellas.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 ↗
2026-04-20 Merck Sharp & Dohme LLC FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer merck.com ↗

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as ENFORTUMAB VEDOTIN ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as AGS-22CE ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as AGS-22M6E ClinicalTrials.gov intervention name — accepted as the source's own label NCT01409135 ↗
Known as AGS-22ME ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as AGS-22MSE ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as Asg-22ce ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as ASG-22ME ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as Enfortumab vedotin ejfv ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as Enfortumab vedotina ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as Enfortumab vedotine ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
Known as Padcev ChEMBL registry synonym — accepted as the source's own label CHEMBL3301589 ↗
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 “Nectin-4 binding agent” CHEMBL3301589 ↗