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Drug

Avelumab

Approved medicine
ClassProgrammed cell death 1 ligand 1 otherResearchActive indication expansion

Also known as Bavencio.

11
Research papers
46
Active clinical trials
Programmed cell death 1 ligand 1
Primary target
15
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: AVELUMAB (BLA761049)

Regulatory2026-08-31FDA

Label change: AVELUMAB (BLA761049)

Regulatory2025-06-04FDA

Label change: AVELUMAB (BLA761049)

Regulatory2024-11-26FDA

Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.

Research2020-09-18The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Avelumab
Aliases & brands
Bavencio
RxNorm CUI
1875534
ChEMBL ID
CHEMBL3833373
ATC codes
L01FF04
UNII
KXG2PJ551I
Primary mechanism
Programmed cell death 1 ligand 1 other
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

OTHERProgrammed cell death 1 ligand 1 other

Regulatory timeline

15 events

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.

Approval / market entry confirmed across FDA and EMA (2017-03-232018-10-19)
Earliest approval
2017-03-23
Latest approval
2024-10-11
Authorities
FDA · EMA
Total events
15
fdaU.S. Food and Drug Administration· 14 events
2026-08-31Label change
Label change: AVELUMAB (BLA761049)
Evidence ↗
2025-06-04Label change
Label change: AVELUMAB (BLA761049)
Evidence ↗
2024-11-26Label change
Label change: AVELUMAB (BLA761049)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2017-09-18ApprovalMulti-authority
Approval: Bavencio (EMA)
Indication: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for theShow full indication

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.

Evidence ↗

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

191 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
191
registered trials across all phases
LATEST COMPLETION 2026
46
Active studies
13
Recruiting
17
Late-stage (III+)
56
Completed
89
Discontinued
PHASE DISTRIBUTIONn = 191
Early Phase 14Phase 134Phase 1 / 244Phase 292Phase 316Phase N / A1

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

11 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20162025
Most influential
Recent papers
Major research themes8
B7-H1 Antigen1Carcinoma, Renal Cell1Circulating Tumor DNA1Colorectal Neoplasms1Immune Checkpoint Inhibitors1Kidney Neoplasms1Neoplasms1Quality of Life1
Journals, researchers & institutions
Top journals
  • Journal for immunotherapy of cancer3
  • JAMA oncology2
  • Annals of oncology : official journal of the European Society for Medical Oncology1
  • ESMO open1
  • Future oncology (London, England)1
  • The Lancet. Oncology1
Leading researchers
  • D'Angelo SP7
  • Lebbé C6
  • Bajars M4
  • Terheyden P4
  • Bhatia S3
  • Brownell I3
  • Grob JJ3
  • Güzel G3
Leading institutions
free-text, unnormalised
  • Memorial Sloan Kettering Cancer Center6
  • Dana-Farber Cancer Institute4
  • Rutgers Cancer Institute of New Jersey4
  • University of Lübeck4
  • University of Washington Medical Center at South Lake Union4
  • Aix-Marseille University3

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 4 of the same disease areas as Avelumab in the shared literature.

4 shared diseases1 shared paper

Studied across 4 of the same disease areas as Avelumab in the shared literature.

4 shared diseases1 shared paper

Studied across 3 of the same disease areas as Avelumab in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Avelumab in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Avelumab in the shared literature.

3 shared diseases1 shared paper

Studied across 2 of the same disease areas as Avelumab in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • 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.