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
Afatinib	US FDA	—	Efficacy supplement 2022-04-07 (see label)	approved	Apr 7, 2022	openfda
Afatinib	US FDA	—	Efficacy supplement 2018-01-12 (see label)	approved	Jan 12, 2018	openfda
Afatinib	US FDA	—	Efficacy supplement 2016-04-15 (see label)	approved	Apr 15, 2016	openfda
Afatinib	US FDA	—	Efficacy supplement 2015-11-09 (see label)	approved	Nov 9, 2015	openfda
Afatinib	US FDA	Lung Non-Small Cell Carcinoma	Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy	approved	Jul 12, 2013	openfda
Afatinib	US FDA	—	Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations	approved	Jul 12, 2013	openfda
Afatinib	US FDA	Lung Non-Small Cell Carcinoma	First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test	approved	Jul 12, 2013	openfda
Amivantamab	US FDA	—	Efficacy supplement 2025-08-14 (see label)	approved	Aug 14, 2025	openfda
Amivantamab	US FDA	—	Efficacy supplement 2024-09-19 (see label)	approved	Sep 19, 2024	openfda
Amivantamab	US FDA	—	Efficacy supplement 2024-08-19 (see label)	approved	Aug 19, 2024	openfda
Amivantamab	US FDA	—	Efficacy supplement 2024-03-01 (see label)	approved	Mar 1, 2024	openfda
Amivantamab	US FDA	—	Efficacy supplement 2022-11-04 (see label)	approved	Nov 4, 2022	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] .	approved	May 21, 2021	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] .	approved	May 21, 2021	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy.	approved	May 21, 2021	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2) ] .	approved	May 21, 2021	openfda
Carboplatin	US FDA	Ovarian Carcinoma	As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma.	approved	Aug 8, 2025	openfda
Carboplatin	US FDA	Ovarian Carcinoma	As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy.	approved	Aug 8, 2025	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
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	Nov 9, 2020	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	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	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	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	US FDA	—	Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.	approved	Aug 28, 2015	openfda
Erlotinib Hydrochloride	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 5, 2019	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
Lazertinib	US FDA	—	Efficacy supplement 2025-08-14 (see label)	approved	Aug 14, 2025	openfda
Lazertinib	US FDA	Lung Non-Small Cell Carcinoma	LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )	approved	Aug 19, 2024	openfda
Osimertinib	US FDA	—	Efficacy supplement 2024-09-25 (see label)	approved	Sep 25, 2024	openfda
Osimertinib	US FDA	—	Efficacy supplement 2024-02-16 (see label)	approved	Feb 16, 2024	openfda
Osimertinib	US FDA	—	Efficacy supplement 2024-01-31 (see label)	approved	Jan 31, 2024	openfda
Osimertinib	US FDA	—	Efficacy supplement 2020-12-18 (see label)	approved	Dec 18, 2020	openfda
Osimertinib	US FDA	—	Efficacy supplement 2020-12-09 (see label)	approved	Dec 9, 2020	openfda
Osimertinib	US FDA	—	Efficacy supplement 2020-05-23 (see label)	approved	May 23, 2020	openfda
Osimertinib	US FDA	—	Efficacy supplement 2018-04-18 (see label)	approved	Apr 18, 2018	openfda
Osimertinib	US FDA	—	Efficacy supplement 2017-03-30 (see label)	approved	Mar 30, 2017	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2025-10-03 (see label)	approved	Oct 3, 2025	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: AXTLE is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.	approved	Jun 28, 2024	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)