PharmaRadar360

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OncologyDrug intelligence

Padcev

Enfortumab Vedotin

Nectin-4-directed antibody-drug conjugate. Developed by Seagen. Clinical, regulatory, and source evidence are connected below.

Company
Seagen
Target / MOA
Nectin-4 · NECTIN4
Aliases
Padcev · ASG-22ME
Signals
23
Clinical trials
18
Approvals
1
Evidence sources
23

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

Phase 1 · RECRUITING · Pfizer

clinical trialClinicalTrials.gov

Enfortumab Vedotin for the Treatment of Unresectable or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer, or NUT Carcinoma

Phase 2 · NOT_YET_RECRUITING · Northwestern University

clinical trialClinicalTrials.gov

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

Phase 2 · COMPLETED · Astellas Pharma China, Inc.

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Padcev · BLA761137 · label version 18, effective Aug 4, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who: • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

European Union (EMA)

Padcev · EMEA/H/C/005392 · Authorised, authorised Apr 13, 2022 (Commission decision C(2022) 2527) · EPAR

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). 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).

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA761137 · ASTELLAS · first approved Dec 18, 2019

7 efficacy supplements approved

European Union

  • Padcev: Authorised since Apr 13, 2022
  • May 21, 2026 · Padcev: CHMP opinion on an extension, positive

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA761137 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

Padcev label

WARNING: SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions. • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )].

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 18 linked records.

Phase 1RECRUITINGNCT07421700

Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

Pfizer · Updated Oct 8, 2026

Phase 2NOT YET RECRUITINGNCT07863765

Enfortumab Vedotin for the Treatment of Unresectable or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer, or NUT Carcinoma

Northwestern University · Updated Oct 7, 2026

Phase 2COMPLETEDNCT04995419

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

Astellas Pharma China, Inc. · Updated Oct 2, 2026

Phase 1RECRUITINGNCT06470282

Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer

University of California, San Francisco · Updated Oct 1, 2026

Phase 4RECRUITINGNCT06764095

Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial

Mayo Clinic · Updated Oct 1, 2026

Phase 3RECRUITINGNCT07566156

Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)

Astellas Pharma Global Development, Inc. · Updated Sep 30, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 8, 202620FDAofficial · Latest Jul 10, 20261EMA Human Medicinesofficial · Latest Oct 16, 20261EMA Newsofficial · Latest Sep 18, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.