Biomarker · Gene alteration

EGFR exon 19 deletion

In-frame deletions in EGFR exon 19 detected by sequencing or PCR; a sensitizing EGFR mutation used as a predictive marker for EGFR tyrosine kinase inhibitors in non-small cell lung cancer.

CI-BIO-00000009EGFR graph →NCIt C126892

Also calledex19del · EGFR del19 · exon 19 del

Derived

Associated cancers (2)

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	21	21	—	—	10 / 7 / 1 / 3 / 0
Lung Adenocarcinoma	10	10	—	—	0 / 7 / 3 / 0 / 0

Derived

Drugs with predictive evidence (13)

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	8	8	—	A	8 / 0	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma
GefitinibSmall Molecule	8	8	—	A	8 / 0	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma

Curated evidence

Predictive evidence items (31)

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

civicCuratedShowing 1–31 of 31 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 Exon 19 Deletion18
Afatinib

Regulatory

Approvals mentioning the linked drugs (225)

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

EGFR Exon 19 Deletion + EGFR L858R10
Erlotinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID3791 The phase 3 (EURTAC) study consisted of of 173 non-small cell lung cancer patients who had not had prior chemotherapy for metastatic disease (although adjuvant or neoadjuvant chemotherapy was permitte… (full text at CIViC) PMID 22285168 · Rosell et al., 2012 · Open in CIViC	civic
Amivantamab + Carboplatin + PemetrexedCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12156 In this phase III trial, 657 patients with locally advanced or metastatic NSCLC (Non-Small Cell Lung Cancer) harbouring EGFR mutations (exon 19 deletions or L858R) were treated with amivantamab plus c… (full text at CIViC) PMID 37879444 · Passaro et al., 2024 · Open in CIViC	civic
Amivantamab + LazertinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12131 In this trial (MARIPOSA), 1074 patients with Non-Small Cell Lung Cancer harbouring exon 19 deletion or exon 21 L858R substitution were randomized (2:2:1) to receive lazertinib-amivantamab (n=429), osi… (full text at CIViC) PMID 38942080 · Felip et al., 2024 · Open in CIViC	civic
Dacomitinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID11239 In this phase 3, open-label, randomized trial, 452 patients with EGFR mutation-positive non-small cell lung cancer including exon 19 deletions and exon 21 L858R point mutations were randomized into co… (full text at CIViC) PMID 28958502 · Wu et al., 2017 · Open in CIViC	civic
Erlotinib + GefitinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID4759 In a study of 1261 non-small cell lung cancer patients, 49.8% of the analyzed tumors had EGFR mutations including deletions in exon 19 (n=258), L858R (n=260), T790M (n=6) and insertions or duplication… (full text at CIViC) PMID 21531810 · Wu et al., 2011 · Open in CIViC	civic
Erlotinib + RamucirumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID11240 In this phase 3, randomized, double-blind, placebo-controlled trial, 449 patients stage IV NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. Patients were randomly assigned in a 1:1 rati… (full text at CIViC) PMID 31591063 · Nakagawa et al., 2019 · Open in CIViC	civic
Gefitinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11241 In this phase-IV, open-label, single-arm study, 106 patients with NSCLC and EGFR mutations including exon 19 deletion and exon 21 L858R point mutations were administered 250 mg daily doses of gefitini… (full text at CIViC) PMID 24263064 · Douillard et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID2156 A phase 2 study of 120 stage IIIB-IV lung adenocarcinoma patients reported improved progression free survival in patients with EGFR mutation (defined as exon 19 deletion or exon 21 mutation) when trea… (full text at CIViC) PMID 24755888 · Yu et al., 2014 · Open in CIViC	civic
Osimertinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID11219 In this phase 3, double-blind trial, 682 patients were randomly assigned 1:1 to either osimertinib (80 mg once daily) or placebo for 3 years following complete resection of EGFR mutation positive (exo… (full text at CIViC) PMID 32955177 · Wu et al., 2020 · Open in CIViC	civic
Chemotherapy + OsimertinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID12015 In this phase 3 clinical trial, 557 patients with NSCLC harbouring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned to two groups and treated with either osimertinib with che… (full text at CIViC) PMID 37937763 · Planchard et al., 2023 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Pemetrexed	US FDA	—	Efficacy supplement 2012-10-17 (see label)	approved	Oct 17, 2012	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2011-11-18 (see label)	approved	Nov 18, 2011	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2011-03-17 (see label)	approved	Mar 17, 2011	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2009-07-02 (see label)	approved	Jul 2, 2009	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2008-09-26 (see label)	approved	Sep 26, 2008	openfda
Pemetrexed	US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.	approved	Feb 4, 2004	openfda
Pemetrexed	US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.	approved	Feb 4, 2004	openfda
Pemetrexed	US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.	approved	Feb 4, 2004	openfda
Pemetrexed	US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.	approved	Feb 4, 2004	openfda
Pemetrexed	US FDA	Pleural Malignant Mesothelioma	initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.	approved	Feb 4, 2004	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.	approved	Feb 4, 2004	openfda
Ramucirumab	CA Health Canada	—	Marketed in Canada as CYRAMZA (DIN 02443805) under ATC L01FG02 RAMUCIRUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 10, 2015	health-canada-dpd
Ramucirumab	EU EMA	—	Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate. Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5?fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Non-small cell lung cancer Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy. Hepatocellular carcinoma Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ? 400 ng/ml and who have been previously treated with sorafenib.	approved	Dec 19, 2014	ema
Ramucirumab	US FDA	—	Efficacy supplement 2025-04-07 (see label)	approved	Apr 7, 2025	openfda
Ramucirumab	US FDA	—	Efficacy supplement 2025-01-27 (see label)	approved	Jan 27, 2025	openfda
Ramucirumab	US FDA	—	Efficacy supplement 2020-05-29 (see label)	approved	May 29, 2020	openfda
Ramucirumab	US FDA	—	Efficacy supplement 2019-05-10 (see label)	approved	May 10, 2019	openfda
Ramucirumab	US FDA	—	Efficacy supplement 2015-04-24 (see label)	approved	Apr 24, 2015	openfda
Ramucirumab	US FDA	—	Efficacy supplement 2014-12-12 (see label)	approved	Dec 12, 2014	openfda
Ramucirumab	US FDA	—	Efficacy supplement 2014-11-05 (see label)	approved	Nov 5, 2014	openfda
Ramucirumab	US FDA	Lung Non-Small Cell Carcinoma	in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.	approved	Apr 21, 2014	openfda
Ramucirumab	US FDA	Hepatocellular Carcinoma	as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.	approved	Apr 21, 2014	openfda
Ramucirumab	US FDA	Malignant Colorectal Neoplasm	in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.	approved	Apr 21, 2014	openfda
Ramucirumab	US FDA	—	as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.	approved	Apr 21, 2014	openfda
Ramucirumab	US FDA	Lung Non-Small Cell Carcinoma	in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.	approved	Apr 21, 2014	openfda

Associated cancers (2)

Drugs with predictive evidence (13)

Predictive evidence items (31)

Approvals mentioning the linked drugs (225)

Active trials (332)

Linked publications (28)