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.

openfdaRegulatory27 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-05-28 (see label)	approved	May 28, 2026	openfda
US FDA	—	Efficacy supplement 2025-11-25 (see label)	approved	Nov 25, 2025	openfda
US FDA	—	Efficacy supplement 2025-03-28 (see label)	approved	Mar 28, 2025	openfda
US FDA	—	Efficacy supplement 2025-02-28 (see label)	approved	Feb 28, 2025	openfda
US FDA	—	Efficacy supplement 2024-12-04 (see label)

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 2 days 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	114	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 51–100 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
NCT04092283	Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer	active not recruiting	Phase 3	660	National Cancer Institute (NCI)NIH	2	Sep 8, 2026	clinicaltrials
NCT07005128	A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

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 26 minutes 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)