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 851–900 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
NCT04117945	Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer	active not recruiting	Phase 2

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
Cetuximab	US FDA	—	Efficacy supplement 2006-03-01 (see label)	approved	Mar 1, 2006	openfda
Cetuximab	US FDA	Head and Neck Squamous Cell Carcinoma	Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.	approved	Feb 12, 2004	openfda
Cetuximab	US FDA	Head and Neck Squamous Cell Carcinoma	Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.	approved	Feb 12, 2004	openfda
Cetuximab	US FDA	Malignant Colorectal Neoplasm	Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.	approved	Feb 12, 2004	openfda
Cetuximab	US FDA	Head and Neck Squamous Cell Carcinoma	Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.	approved	Feb 12, 2004	openfda
Cetuximab	US FDA	Malignant Colorectal Neoplasm	Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.	approved	Feb 12, 2004	openfda
Cisplatin	US FDA	—	Efficacy supplement 1993-04-22 (see label)	approved	Apr 22, 1993	openfda
Cisplatin	US FDA	—	Efficacy supplement 1981-12-29 (see label)	approved	Dec 29, 1981	openfda
Cisplatin	US FDA	Malignant Bladder Neoplasm	INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.	approved	Dec 19, 1978	openfda
Crizotinib	US FDA	Anaplastic Large Cell Lymphoma	o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.	approved	Sep 7, 2023	openfda
Crizotinib	US FDA	Anaplastic Large Cell Lymphoma	pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.	approved	Sep 7, 2023	openfda
Crizotinib	US FDA	—	Efficacy supplement 2023-09-07 (see label)	approved	Sep 7, 2023	openfda
Crizotinib	US FDA	—	XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.	approved	Sep 7, 2023	openfda
Crizotinib	US FDA	—	Efficacy supplement 2022-07-14 (see label)	approved	Jul 14, 2022	openfda
Crizotinib	US FDA	—	Efficacy supplement 2021-01-14 (see label)	approved	Jan 14, 2021	openfda
Crizotinib	US FDA	—	Efficacy supplement 2018-11-30 (see label)	approved	Nov 30, 2018	openfda
Crizotinib	US FDA	—	Efficacy supplement 2017-04-28 (see label)	approved	Apr 28, 2017	openfda
Crizotinib	US FDA	—	Efficacy supplement 2016-03-11 (see label)	approved	Mar 11, 2016	openfda
Crizotinib	US FDA	—	Efficacy supplement 2015-09-14 (see label)	approved	Sep 14, 2015	openfda
Crizotinib	US FDA	—	Efficacy supplement 2013-11-20 (see label)	approved	Nov 20, 2013	openfda
Crizotinib	US FDA	Anaplastic Large Cell Lymphoma	pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.	approved	Aug 26, 2011	openfda
Crizotinib	US FDA	—	XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.	approved	Aug 26, 2011	openfda
Crizotinib	US FDA	Anaplastic Large Cell Lymphoma	o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.	approved	Aug 26, 2011	openfda
Dacomitinib	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
Datopotamab Deruxtecan	US FDA	—	Efficacy supplement 2026-05-22 (see label)	approved	May 22, 2026	openfda
Datopotamab Deruxtecan	US FDA	Triple-Negative Breast Carcinoma	This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ] .accelerated	approved	Jan 17, 2025	openfda
Datopotamab Deruxtecan	US FDA	Malignant Breast Neoplasm	adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.	approved	Jan 17, 2025	openfda
Datopotamab Deruxtecan	US FDA	Lung Non-Small Cell Carcinoma with EGFR Mutation	adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.	approved	Jan 17, 2025	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Oct 23, 2024	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	Oct 23, 2024	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	Oct 23, 2024	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	Oct 23, 2024	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Nov 22, 2022	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	Nov 22, 2022	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	Nov 22, 2022	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC	approved	Nov 22, 2022	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	Nov 22, 2022	openfda
Docetaxel	US FDA	—	Efficacy supplement 2019-01-08 (see label)	approved	Jan 8, 2019	openfda
Docetaxel	US FDA	—	Efficacy supplement 2014-07-10 (see label)	approved	Jul 10, 2014	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Apr 12, 2013	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	Apr 12, 2013	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	Apr 12, 2013	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	Apr 12, 2013	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 29, 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 29, 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 29, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Jun 29, 2011	openfda