Biomarker · Gene alteration

EGFR mutation (any sensitizing or resistance mutation)

Somatic mutations of the EGFR tyrosine kinase domain detected by sequencing or PCR in tumor tissue or plasma; used as a predictive marker for EGFR tyrosine kinase inhibitors, chiefly in non-small cell lung cancer.

CI-BIO-00000008EGFR graph →NCIt C98357

Also calledEGFR-mutant · EGFR-mutated · EGFR activating mutation

Derived

Associated cancers (20)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Lung Non-Small Cell Carcinoma	152	149	3	—	28 / 52 / 32 / 39 / 1
Lung Adenocarcinoma	46	44	2	—	1 / 18 / 25 / 2 / 0
Malignant Colorectal Neoplasm	17	17	—	—	0 / 5 / 4 / 7 / 1
Malignant Neoplasm	14	14	—	—	0 / 0 / 0 / 14 / 0
Head and Neck Squamous Cell Carcinoma

Derived

Drugs with predictive evidence (39)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
ErlotinibSmall Molecule	99	78	21	A	71 / 21	Colon Adenocarcinoma, Glioblastoma, High-Grade Glioma, NOS, Lung Adenocarcinoma +6
GefitinibSmall Molecule	69	59	10

Curated evidence

Predictive evidence items (252)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–50 of 252 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 Expression1
Lapatinib

Regulatory

Approvals mentioning the linked drugs (475)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfda

Clinical trials

Active trials (936)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 468 recruiting · 247 active phase 3 · 3,992 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 801–850 of 936 active 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
NCT06825624	ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer	recruiting	Phase 1	560	Hansoh BioMedical R&D Company

Literature

Linked publications (141)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 141 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

EGFR T790M resistance mutation in non small-cell lung carcinoma.
· Clin Chim Acta · 2015 · PMID 25668228 · validated civic_curation pubmed
Osimertinib: First Global Approval.
· Drugs · 2016 · PMID 26729184 · validated civic_curation pubmed
Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.
· N Engl J Med · 2017 · PMID 27959700 · validated civic_curation pubmed
U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.
· Oncologist · 2014 · PMID 24868098 · validated

EGFR Overexpression3
Nimotuzumab	Esophageal Squamous Cell CarcinomaALIAS	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID783 55 tumor samples were analyzed for EGFR expression using IHC. The objective response rate to anti-EGFR antibody nimotuzumab did not differ significantly between EGFR high- (18 pts) and EGFR low to mod… (full text at CIViC) PMID 26459251 · Jia et al., 2016 · Open in CIViC	civic
Cetuximab	Head and Neck Squamous Cell Carcinoma	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID692 EGFR expression level was not predicitive of response to cetuximab-containing first line regimens in recurrent or metastatic head and neck squamous cell carcinoma and KRAS-wild type colorectal carcino… (full text at CIViC) PMID 23265711 · Licitra et al., 2013 · Open in CIViC	civic
Cetuximab + DocetaxelCombination	Head and Neck Squamous Cell Carcinoma	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID849 47 HNSCC patients treated with cetuximab/docetaxel were retrospectively analyzed for EGFRvIII, EGFR and AREG expression with IHC. 73 % of cases expressed high level of EGFR. EGFR expression had no imp… (full text at CIViC) PMID 21653686 · Tinhofer et al., 2011 · Open in CIViC	civic

EGFR VIII5
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID772 49 patients (26 pretreatment tissues available for analysis) with recurrent glioblastomas who were treated with EGFR TKIs were analyzed in this study. Results were confirmed in an independent cohort o… (full text at CIViC) PMID 16282176 · Mellinghoff et al., 2005 · Open in CIViC	civic
Erlotinib + GefitinibSubstitutes	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1128 Expression of EGFRvIII and PTEN was evaluated in 26 patients with glioblastomas treated with erlotinib or gefitinib and no EGFR or Her2/neu kinase domain mutations. 7 patients responded to treatment w… (full text at CIViC) PMID 16282176 · Mellinghoff et al., 2005 · Open in CIViC	civic
Rindopepimut	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID971 In a Phase II clinical trial, patients with Glioblastoma Multiforme (GBM), positive for EGFR VIII deletion mutation (N=65), were treated with the Rindopepimut cancer vaccine, and standard adjuvant te… (full text at CIViC) PMID 25586468 · Schuster et al., 2015 · Open in CIViC	civic
Cetuximab + DocetaxelCombination	Head and Neck Squamous Cell Carcinoma	Predictive	B	Supports Resistance	2	accepted	EID848 47 HNSCC patients treated with cetuximab/docetaxel were retrospectively analyzed for EGFRvIII, EGFR, and AREG expression by IHC. 17% of cases expressed high levels of EGFRvIII. High vIII expression wa… (full text at CIViC) PMID 21653686 · Tinhofer et al., 2011 · Open in CIViC	civic
Erlotinib	High-Grade Glioma, NOS	Predictive	D	Supports Sensitivity Response	3	accepted	EID4500 In an in vitro study, a Ba/F3 cell line expressing EGFR vIII demonstrated increased sensitivity to erlotinib treatment, compared to Ba/F3 cells expressing EGFR wild-type. Variant function was assessed… (full text at CIViC) PMID 17177598 · Lee et al., 2006 · Open in CIViC	civic

EGFR L858R9
Erlotinib	High-Grade Glioma, NOS	Predictive	D	Supports Sensitivity Response	3	accepted	EID4295 In an in vitro study, a Ba/F3 cell line expressing EGFR L858R demonstrated increased sensitivity to erlotinib treatment, compared to Ba/F3 cells expressing EGFR wild-type. Variant function was assesse… (full text at CIViC) PMID 17177598 · Lee et al., 2006 · Open in CIViC	civic
Afatinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID879 A phase III clinical trial (NCT00949650) found that median progression free survival among patients with exon 19 deletions or L858R EGFR mutations (n = 308) was 13.6 months for afatinib and 6.9 months… (full text at CIViC) PMID 23816960 · Sequist et al., 2013 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID883 In a phase 2 study of patients with lung adenocarcinoma (stage IIIb with pleural effusion or stage IV) and EGFR mutations, treated with afatinib were assessed by objective response. 129 patients were … (full text at CIViC) PMID 22452895 · Yang et al., 2012 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID982 Afatinib is an irreversible covalent inhibitor of EGFR (second generation). This Phase III clinical trial (LUX-Lung 6; NCT01121393) was performed in Asian patients with EGFR mutant advanced NSCLC. 364… (full text at CIViC) PMID 24439929 · Wu et al., 2014 · Open in CIViC	civic
Cetuximab	Lung Adenocarcinoma	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID4292 In an in vitro study, Ba/F3 cell line expressing EGFR L858R did not show sensitivity to cetuximab treatment, while cells expressing EGFR-RAD51 fusion were sensitive. Sensitivity was determined by asse… (full text at CIViC) PMID 27102076 · Konduri et al., 2016 · Open in CIViC	civic
Erlotinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	2	accepted	EID4290 In a prospective study of 46 Caucasian, advanced lung adenocarcinoma patients harboring EGFR mutations, first-line erlotinib treatment was assessed. Average PFS and OS for these 46 patients was 11 mon… (full text at CIViC) PMID 27032107 · De Grève et al., 2016 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID4291 In an in vitro study, Ba/F3 cell line expressing EGFR L858R was associated with sensitivity to erlotinib treatment (IC50 26.9 ± 12.4nM). EGFR L858R was used as a positive control for comparing sensiti… (full text at CIViC) PMID 27102076 · Konduri et al., 2016 · Open in CIViC	civic
Gefitinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID2634 In a phase 3 clinical trial of Korean, never-smoker, lung adenocarcinoma patients, a subset of patients with EGFR mutations (n=42) treated with gefitinib were associated with improved overall response… (full text at CIViC) PMID 22370314 · Han et al., 2012 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	2	accepted	EID6183 In a Japanese Phase III clinical trial, noninferiority of Gefitinib as compared to Erlotinib was assessed in 561 postoperative recurrent or stage IIIb/VI patients who had undergone prior chemotherapy … (full text at CIViC) PMID 27022112 · Urata et al., 2016 · Open in CIViC	civic

EGFR Exon 19 Deletion6
Afatinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID880 A phase III clinical trial (NCT00949650) found that median progression free survival among patients with EGFR exon 19 deletion was 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 9… (full text at CIViC) PMID 23816960 · Sequist et al., 2013 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID882 In a phase 2 study (NCT00525148), patients with lung adenocarcinoma (stage IIIb with pleural effusion or stage IV) and EGFR mutations, treated with afatinib, were assessed by objective response. In to… (full text at CIViC) PMID 22452895 · Yang et al., 2012 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID981 Afatinib is an irreversible covalent inhibitor of EGFR (second generation). This Phase III clinical trial (LUX-Lung 6; NCT01121393) was performed in Asian patients with EGFR mutant advanced NSCLC. 364… (full text at CIViC) PMID 24439929 · Wu et al., 2014 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID983 In analysis of LUX-Lung 3 and LUX-Lung 6 trials (NCT00949650 and NCT01121393), of EGFR mutant NSCLC, median overall survival with afatinib treatment was seen to be significantly improved over chemothe… (full text at CIViC) PMID 25589191 · Yang et al., 2015 · Open in CIViC	civic
Erlotinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	—	accepted	EID4766 In a stage IV lung adenocarcinoma patient harboring EGFR exon 19 deletion, EGFR exon 19 deletion was associated with sensitivity to erlotinib monotherapy. Prior to identification of the EGFR exon 19 d… (full text at CIViC) PMID 27566387 · Kanemaru et al., 2016 · Open in CIViC	civic
Gefitinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID2519 In a phase 3 clinical trial of Korean, never-smoker, lung adenocarcinoma patients, a subset of patients with EGFR mutations (n=42) treated with gefitinib were associated with improved overall response… (full text at CIViC) PMID 22370314 · Han et al., 2012 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	May 3, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	May 3, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	May 3, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	May 3, 2011	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	May 3, 2011	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Mar 8, 2011	openfda
Docetaxel	US FDA	—	Efficacy supplement 2010-05-13 (see label)	approved	May 13, 2010	openfda
Docetaxel	US FDA	—	Efficacy supplement 2007-09-28 (see label)	approved	Sep 28, 2007	openfda
Docetaxel	US FDA	—	Efficacy supplement 2006-10-17 (see label)	approved	Oct 17, 2006	openfda
Docetaxel	US FDA	—	Efficacy supplement 2006-03-22 (see label)	approved	Mar 22, 2006	openfda
Docetaxel	US FDA	—	Efficacy supplement 2004-08-18 (see label)	approved	Aug 18, 2004	openfda
Docetaxel	US FDA	—	Efficacy supplement 2004-05-19 (see label)	approved	May 19, 2004	openfda
Docetaxel	US FDA	—	Efficacy supplement 2002-11-27 (see label)	approved	Nov 27, 2002	openfda
Docetaxel	US FDA	—	Efficacy supplement 1999-12-23 (see label)	approved	Dec 23, 1999	openfda
Docetaxel	US FDA	—	Efficacy supplement 1998-06-22 (see label)	approved	Jun 22, 1998	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	May 14, 1996	openfda
Docetaxel	US FDA	Lung Non-Small Cell Carcinoma	Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC	approved	May 14, 1996	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	May 14, 1996	openfda
Docetaxel	US FDA	Head and Neck Squamous Cell Carcinoma	Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	approved	May 14, 1996	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer	approved	May 14, 1996	openfda
Durvalumab	US FDA	Lung Non-Small Cell Carcinoma	in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.	approved	May 1, 2017	openfda
Erlotinib	US FDA	—	Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.	approved	Nov 9, 2020	openfda
Erlotinib	US FDA	Malignant Pancreatic Neoplasm	First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.	approved	Nov 9, 2020	openfda
Erlotinib	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations.	approved	Nov 9, 2020	openfda
Erlotinib	US FDA	Lung Non-Small Cell Carcinoma	The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.	approved	Nov 9, 2020	openfda
Erlotinib	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations.	approved	Aug 28, 2015	openfda
Erlotinib	US FDA	Malignant Pancreatic Neoplasm	First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.	approved	Aug 28, 2015	openfda
Erlotinib	US FDA	—	Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.	approved	Aug 28, 2015	openfda
Erlotinib	US FDA	Lung Non-Small Cell Carcinoma	The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.	approved	Aug 28, 2015	openfda
Erlotinib Hydrochloride	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: Safety and efﬁcacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations.	approved	Nov 5, 2019	openfda
Fluorouracil	US FDA	Colon Adenocarcinoma	FAVLYXA is a nucleoside metabolic inhibitor indicated for the treatment of patients with: Adenocarcinoma of the Colon and Rectum	approved	Feb 20, 2026	openfda
Fluorouracil	US FDA	Breast Adenocarcinoma	Adenocarcinoma of the Breast	approved	Feb 20, 2026	openfda
Fluorouracil	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma	approved	Feb 20, 2026	openfda
Fluorouracil	US FDA	Pancreatic Adenocarcinoma	Pancreatic Adenocarcinoma	approved	Feb 20, 2026	openfda
Fluorouracil	US FDA	—	Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor indicated for the topical treatment of actinic keratosis lesions of the face, ears, and scalp ( 1 ).	approved	Sep 18, 2015	openfda
Fluorouracil	US FDA	—	Original approval 1970-07-29 — label text not available on openFDA	approved	Jul 29, 1970	openfda
Gefitinib	US FDA	Lung Non-Small Cell Carcinoma	IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ] . IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. (1) Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1)	approved	Jul 13, 2015	openfda
Lapatinib	US FDA	—	Efficacy supplement 2018-12-06 (see label)	approved	Dec 6, 2018	openfda
Lapatinib	US FDA	—	Efficacy supplement 2013-10-18 (see label)	approved	Oct 18, 2013	openfda
Lapatinib	US FDA	—	Efficacy supplement 2013-10-18 (see label)	approved	Oct 18, 2013	openfda
Lapatinib	US FDA	—	Efficacy supplement 2010-01-29 (see label)	approved	Jan 29, 2010	openfda