Drug · Small Molecule

Afatinib

CI-DRUG-00000043Explore in graph →NCIt C66940 CHEMBL1173655 CIViC Approved

Regulatory

Approvals (20)

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

openfdaRegulatory7 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2022-04-07 (see label)	approved	Apr 7, 2022	openfda
US FDA	—	Efficacy supplement 2018-01-12 (see label)	approved	Jan 12, 2018

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 13 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	19	10	17	146	20	CA, EU, US	Jul 12, 2013	2003-11
Malignant Lung Neoplasm	Approved	Phase 4	4	1	11	50	3	EU, US	Jul 12, 2013	2007-08
Multiple Myeloma	Phase2	Phase 2	3	0	0	4	0	—	—	Aug 12, 2015
Non-Hodgkin Lymphoma	Phase2	Phase 2	3	0	0	4	0	—

Curated evidence

Clinical evidence (132)

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

civicCuratedShowing 51–100 of 132 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 E746_A750del1
Afatinib	Lung Non-Small Cell Carcinoma

Clinical trials

Trials with this intervention (163)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–150 of 163 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
NCT02271906	The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting	terminated	Phase 2	2	M.D. Anderson Cancer CenterOTHER	1	Apr 30, 2019	clinicaltrials
NCT02595840	Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)(Trans-MARBLE)	terminated

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: V1T5K7RZ0B
Aliases: (2e)-N-(4-(3-Chloro-4-Fluoroanilino)-7-(((3s)-Oxolan-3-yl)Oxy)Quinoxazolin-6-yl)-4-(Dimethylamino)But-2-Enamide, Afatinib, AFATINIB (BIBW2992), Afatinib Dimaleate, AFATINIB DIMALEATE, AFATINIB FREE BASE, BIBW 2992, BIBW-2992, BIBW2992, BIBW2992 (AFATINIB), BIBW2992AFATINIBTOVOKS1011, BIBW2992-MA2, (E/Z)-AFATINIB, (E/Z)-BIBW 2992, GILOTRIF, Giotrif, GIOTRIF, MAR-AFATINIB, NSC-750691, SANDOZ AFATINIB, TEVA-AFATINIB, TOMTOVOK, TOVOK

Data updated 16 hours agoSource updated unknown

Identifiers

Codes (27)

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

System	Code	Label
ATC (WHO)	L01EB03	AFATINIB
ATC (WHO)	L01XE13

EGFR E746_S752delinsD2
Afatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2571 In a phase 2b/3 study of 585 stage IIIB-IV lung adenocarcinoma patients who had a previous round of EGFR-TKI treatment, archival material was available for 141 patients. EGFR mutational analysis revea… (full text at CIViC) PMID 22452896 · Miller et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2572 A phase 3 study of 345 stage IIIB-IV lung adenocarcinoma patients, reported improved median progression free survival (13.6 months vs. 6.9 months, HR: 0.47, 95% CI: 0.34-0.65, P=0.001) in EGFR mutatio… (full text at CIViC) PMID 23816960 · Sequist et al., 2013 · Open in CIViC	civic

EGFR E746_T751>I2
Afatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2527 In a study of 585 non-small cell lung cancer patients who had a previous round of EGFR-TKI treatment, archival material was available for 141 patients. EGFR mutational analysis revealed that 96 tumors… (full text at CIViC) PMID 22452896 · Miller et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2528 A phase 3 study of 345 stage IIIB-IV lung adenocarcinoma patients, reported improved median progression free survival (13.6 months vs. 6.9 months, HR: 0.47, 95% CI: 0.34-0.65, P=0.001) in EGFR mutatio… (full text at CIViC) PMID 23816960 · Sequist et al., 2013 · Open in CIViC	civic

EGFR E746V2
Afatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2540 In a study of 585 non-small cell lung cancer patients who had a previous round of EGFR-TKI treatment, archival material was available for 141 patients. EGFR mutational analysis revealed that 96 tumors… (full text at CIViC) PMID 22452896 · Miller et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2541 A phase 3 study of 345 stage IIIB-IV lung adenocarcinoma patients, reported improved median progression free survival (13.6 months vs. 6.9 months, HR: 0.47, 95% CI: 0.34-0.65, P=0.001) in EGFR mutatio… (full text at CIViC) PMID 23816960 · Sequist et al., 2013 · Open in CIViC	civic

EGFR Exon 19 Deletion4
Afatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID2996 Afatinib, an irreversible inhibitor of the ErbB family of tyrosine kinases has been approved in the US for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) who h… (full text at CIViC) PMID 23982599 · Dungo et al., 2013 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID881 Stable HEK293 cell lines expressing mutant EGFR cDNAs were created (using a pQCLIN retroviral vector) and their drug sensitivities to afatinib were examined by MTT assay. Phorphorylation of EGFR was a… (full text at CIViC) PMID 25862853 · Banno et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID969 Cells harboring an exon 19 deletion were sensitive to afatinib. This study performed drug response assays using five human NSCLC cell lines with various combinations of EGFR mutations. In order to dir… (full text at CIViC) PMID 26515464 · Hirano et al., 2015 · Open in CIViC	civic
Afatinib + Erlotinib + GefitinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID12202 The goal of this study was to assess the frequency, overall survival, and classifying actionability of EGFR mutations in NSCLC within the Dutch population from 2013-2017. This study found that despite… (full text at CIViC) PMID 34298851 · Koopman et al., 2021 · Open in CIViC	civic

EGFR L747_A750delinsP2
Afatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2550 In a phase 2b/3 study of 585 stage IIIB-IV lung adenocarcinoma patients who had a previous round of EGFR-TKI treatment, archival material was available for 141 patients. EGFR mutational analysis revea… (full text at CIViC) PMID 22452896 · Miller et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID2551 A phase 3 study of 345 stage IIIB-IV lung adenocarcinoma patients, reported improved median progression free survival (13.6 months vs. 6.9 months, HR: 0.47, 95% CI: 0.34-0.65, P=0.001) in EGFR mutatio… (full text at CIViC) PMID 23816960 · Sequist et al., 2013 · Open in CIViC	civic