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Drug

Durvalumab

Approved medicine

Primarily used for Non-Small-Cell Lung Carcinoma.

ClassProgrammed cell death 1 ligand 1 inhibitorResearchActive indication expansion

Also known as Imfinzi.

13
Research papers
106
Active clinical trials
Programmed cell death 1 ligand 1
Primary target
29
Regulatory events
Latest activity
beta

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

Imfinzi-Imdelltra combo builds frontline SCLC case on Phase III win

Clinical trial2026-09-09Trial news · Clinical Trials Arena

Durvalumab and Standard Chemotherapy for the Treatment of Lymph Node Positive Bladder Cancer

Clinical trial2026-08-31Primary completion · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Durvalumab
Aliases & brands
Imfinzi
RxNorm CUI
1919503
ChEMBL ID
CHEMBL3301587
ATC codes
L01FF03
UNII
28X28X9OKV
Primary mechanism
Programmed cell death 1 ligand 1 inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORProgrammed cell death 1 ligand 1 inhibitor

Regulatory timeline

29 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 (2017-05-012018-09-21)
Earliest approval
2017-05-01
Latest approval
2026-05-28
Authorities
FDA · EMA
Total events
29
fdaU.S. Food and Drug Administration· 28 events
2026-08-31Label change
Label change: DURVALUMAB (BLA761069)
Evidence ↗
2026-05-28Indication expansion
Indication expansion: DURVALUMAB (BLA761069)
Evidence ↗
2025-11-25Indication expansion
Indication expansion: DURVALUMAB (BLA761069)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2018-09-21ApprovalMulti-authority
Approval: Imfinzi (EMA)
Indication: Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, isShow full indication

Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).  Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

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

198 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
198
registered trials across all phases
LATEST COMPLETION 2026
106
Active studies
47
Recruiting
32
Late-stage (III+)
49
Completed
43
Discontinued
PHASE DISTRIBUTIONn = 198
Early Phase 11Phase 133Phase 1 / 223Phase 2109Phase 2 / 31Phase 325Phase 44Phase N / A2

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

13 papers

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

Publications over time
20182024
Most influential
Recent papers
Major research themes8
Antibodies, Monoclonal4Antibodies, Monoclonal, Humanized4Carcinoma, Non-Small-Cell Lung4Lung Neoplasms4Antineoplastic Agents2Antineoplastic Combined Chemotherapy Protocols2Bile Duct Neoplasms1Biomarkers, Tumor1
Journals, researchers & institutions
Top journals
  • JAMA oncology2
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • Nature medicine2
  • Annals of oncology : official journal of the European Society for Medical Oncology1
  • Cancer discovery1
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
Leading researchers
  • Cho BC3
  • Forde PM3
  • Vicente D3
  • Anagnostou V2
  • Antonia SJ2
  • Chen EX2
  • Cheng LY2
  • Garon EB2
Leading institutions
free-text, unnormalised
  • Sarah Cannon Research Institute3
  • Asan Medical Center2
  • Asklepios Lung Clinic2
  • Bloomberg-Kimmel Institute for Cancer Immunotherapy2
  • Centre Hospitalier Universitaire Vaudois2
  • Hospital Universitario Virgen Macarena2

Related diseases

5 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

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

Studied across 9 of the same disease areas as Durvalumab in the shared literature.

9 shared diseases6 shared papers

Studied across 10 of the same disease areas as Durvalumab in the shared literature.

10 shared diseases1 shared paper

Studied across 6 of the same disease areas as Durvalumab in the shared literature.

6 shared diseases1 shared paper

Studied across 5 of the same disease areas as Durvalumab in the shared literature.

5 shared diseases1 shared paper

Studied across 5 of the same disease areas as Durvalumab in the shared literature.

5 shared diseases1 shared paper

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

4 shared diseases1 shared paper

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

3 shared diseases1 shared paper

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

3 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.