Drug · Monoclonal Antibody

Durvalumab

CI-DRUG-00000198Explore in graph →NCIt C103194 CHEMBL3301587 CIViC Approved

Regulatory

Approvals (29)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as IMFINZI (DIN 02468816) under ATC L01FF03 DURVALUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 20, 2017	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 19 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	292	113	91	640	29	CA, EU, US	May 1, 2017	Sep 5, 2012
Malignant Lung Neoplasm	Approved	Phase 4	92	32	38	197	4	US	May 1, 2017	Oct 25, 2013
Malignant Liver Neoplasm	Approved	Phase 3	46	24	9	65	1	US	May 1, 2017	Oct 19, 2015
Malignant Bladder Neoplasm	Approved	Phase 3	12	4	1	25

Curated evidence

Clinical evidence (11)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–11 of 11 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
High3
Durvalumab	Head and Neck Squamous Cell Carcinoma

Clinical trials

Trials with this intervention (653)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 201–250 of 653 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07081633	Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma(TREMENDOUS-2)	active not recruiting	Phase 2	114	AstraZenecaINDUSTRY	2	May 12, 2026	clinicaltrials
NCT03601455	Radiation Therapy and Durvalumab With or Without Tremelimumab in Treating Participants With Unresectable, Locally Advanced, or Metastatic Bladder Cancer

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Programmed cell death 1 ligand 1 inhibitor
Targets: 1 gene
UNII: 28X28X9OKV
Aliases: Durvalumab, Imfinzi, IMFINZI, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide With Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736, MEDI4736

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (5)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FF03	DURVALUMAB
ATC (WHO)	L01XC28	Antineoplastic agents
DIN (Health Canada)

CD274 Expression1
Atezolizumab + Avelumab + Durvalumab + Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4857 In this meta-analysis of 14 studies with 2857 patients, the immunotherapy response rate was higher among PD-L1-positive patients (RR: 2.19, 95% CI: 1.63-2.94). PD-L1 expression was also related to bet… (full text at CIViC) PMID 28472902 · Aguiar et al., 2017 · Open in CIViC	civic

CD274 Expression1

Atezolizumab + Avelumab + Durvalumab + Nivolumab + PembrolizumabSubstitutes

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID4857

In this meta-analysis of 14 studies with 2857 patients, the immunotherapy response rate was higher among PD-L1-positive patients (RR: 2.19, 95% CI: 1.63-2.94). PD-L1 expression was also related to bet… (full text at CIViC)

PMID 28472902 · Aguiar et al., 2017 · Open in CIViC

civic

CD274 v2421
Atezolizumab + Avelumab + DurvalumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	E	Supports Resistance	4	submitted	EID9695 In an in vivo study, mice injected with v242 show significantly reduced survival compared to mice expressing WT (p < 0.001) when treated with anti-PD-L1 antibody. Moreover mixing only 1% MC38 cells wi… (full text at CIViC) PMID 30872362 · Gong et al., 2019 · Open in CIViC	civic

CD274 v2421

Atezolizumab + Avelumab + DurvalumabSubstitutes

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Resistance

submitted

EID9695

In an in vivo study, mice injected with v242 show significantly reduced survival compared to mice expressing WT (p < 0.001) when treated with anti-PD-L1 antibody. Moreover mixing only 1% MC38 cells wi… (full text at CIViC)

PMID 30872362 · Gong et al., 2019 · Open in CIViC

civic

EGFR E746_A750del1
Durvalumab	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID2518 In an in vitro study using PC9 cells (EGFR exon 19 deletion), inhibition of cell viability was used as an assay to determine sensitivity to EGFR tyrosine kinase inhibitors. PC9 cells demonstrated an i… (full text at CIViC) PMID 24893891 · Cross et al., 2014 · Open in CIViC	civic

EGFR E746_A750del1

Durvalumab

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

—

submitted

EID2518

In an in vitro study using PC9 cells (EGFR exon 19 deletion), inhibition of cell viability was used as an assay to determine sensitivity to EGFR tyrosine kinase inhibitors. PC9 cells demonstrated an i… (full text at CIViC)

PMID 24893891 · Cross et al., 2014 · Open in CIViC

civic

EGFR L858R1

Durvalumab

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

rejected

EID2633

EGFR L858R mutation has been associated with increased sensitivity to first generation EGFR tyrosine kinase inhibitors, including erlotinib and gefitinib.In an in vitro study using PC9 cells (EGFR L85… (full text at CIViC)

PMID 24893891 · Cross et al., 2014 · Open in CIViC

civic

PBRM1 Loss-of-function1

Atezolizumab + DurvalumabSubstitutes

Renal Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID7537

Among 35 patients with clear cell RCC, loss-of-function mutation of PBRM1 were correlated with response to anti-PD-1 monotherapy (P = 0.012). It was confirmed in an independent validation cohort of 63… (full text at CIViC)

PMID 29301960 · Miao et al., 2018 · Open in CIViC

civic

MSH2 Loss1

Anti-PD-1 Monoclonal Antibody MEDI0680 + DurvalumabCombination

Transitional Cell Carcinoma

Predictive

Supports Sensitivity Response

accepted

EID1877

Case report of a 45-year old woman of Japanese descent with recurrent urothelial carcinoma. The patient was identified to harbor mutations in MSH2 (A913fs*2, E226*, E580*) and in MSH6 (R361H) by panel… (full text at CIViC)

PMID 26674132 · Castro et al., 2015 · Open in CIViC

civic

MSH6 LOSS1

Anti-PD-1 Monoclonal Antibody MEDI0680 + DurvalumabCombination

Transitional Cell Carcinoma

Predictive

Supports Sensitivity Response

accepted

EID1878

PMID 26674132 · Castro et al., 2015 · Open in CIViC

civic

CD274 Amplification1

Durvalumab

Triple-Negative Breast CarcinomaALIAS

Predictive

Supports Sensitivity Response

submitted

EID12054

Sensitivity to durvalumab was tested in patients with triple-negative breast cancer (TNBC) harbouring CD274 gain/amplification. CD274 amplifications were noted in 42% (n=23) of the TNBC samples. Patie… (full text at CIViC)

PMID 33462450 · Bachelot et al., 2021 · Open in CIViC

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