Drug · Small Molecule

Dacomitinib

CI-DRUG-00000175Explore in graph →NCIt C53398 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	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	1	17	1	US	Sep 27, 2018	Oct 11, 2005
Malignant Lung Neoplasm	Approved	Phase 3	1	7	1	US	Sep 27, 2018	Feb 5, 2008
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	0	1	0	—	—	2010-04
Malignant Gastric Neoplasm	Phase2	Phase 2	0	1

Curated evidence

Clinical evidence (16)

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

civicCuratedShowing 1–16 of 16 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
PTEN Expression1
Dacomitinib	Glioblastoma

Clinical trials

Trials with this intervention (17)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–17 of 17 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
NCT00728390	A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks	completed	Phase 1	74	PfizerINDUSTRY	3	Apr 22, 2024	clinicaltrials
NCT01000025	PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer	completed	Phase 3

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, EGFR Inhibitor PF-00299804, PF 00299804, PF00299804, PF-00299804-03, PF-299804, Vizimpro, VIZIMPRO

Data updated 23 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.

ERBB2 G778_P780dup2
Dacomitinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1048 In this phase II study (NCT00818441) of dacomitinib in HER2 amplified or mutant NSCLC tumors, three of 26 patients with HER2 p.P780_Y781insGSP or p.M774delinsWLV showed partial responses of duration b… (full text at CIViC) PMID 25899785 · Kris et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1892 Phase 2 trial of ERBB-inhibitor dacomitinib in stage IIIB/IV lung cancers with HER2 mutations or amplification. Two patients were identified with identical HER2 p.G778_P780dup mutations (p. P780_Y781i… (full text at CIViC) PMID 25899785 · Kris et al., 2015 · Open in CIViC	civic

ERBB2 G778_P780dup2

Dacomitinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1048

In this phase II study (NCT00818441) of dacomitinib in HER2 amplified or mutant NSCLC tumors, three of 26 patients with HER2 p.P780_Y781insGSP or p.M774delinsWLV showed partial responses of duration b… (full text at CIViC)

PMID 25899785 · Kris et al., 2015 · Open in CIViC