Drug · Small Molecule

Dacomitinib

CI-DRUG-00000176Explore in graph →NCIt C95799 CHEMBL2105719 CIViC Approved

Regulatory

Approvals (1)

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

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Lung Non-Small Cell Carcinoma	VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )	approved	Sep 27, 2018	openfda

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	—	0	0	0	0	1	US	Sep 27, 2018	—
Malignant Lung Neoplasm	Approved	—	0	0	0	0	1	US	Sep 27, 2018	—

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (1)

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

civicCuratedShowing 1–1 of 1 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
EGFR N771delinsGY1
Dacomitinib

Clinical trials

Trials with this intervention (0)

Data not yet available

No registered study lists this drug as an intervention yet.

Molecule

Record

Kind: Small Molecule
Mechanism: Epidermal growth factor receptor erbB1 inhibitor; Receptor protein-tyrosine kinase erbB-2 inhibitor; Receptor protein-tyrosine kinase erbB-4 inhibitor
Targets: 3 genes
UNII: 5092U85G58
Aliases: (2E)-N-(4-((3-Chloro-4-Fluorophenyl)Amino)-7-Methoxyquinazolin-6-yl)-4-Piperidin-1-ylbut-2-Enamide, Dacomitinib, Dacomitinib hydrate, Dacomitinib monohydrate, PF-00299804-03, PF-299804, VIZIMPRO

Data updated 10 hours agoSource updated unknown

Identifiers

Codes (0)

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

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.