EGFR exon 19 deletion

Clinical trials

Active trials (334)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 153 recruiting · 96 active phase 3 · 1,225 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 251–300 of 334 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
NCT07229729	A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer	recruiting	Phase 2	300	Shanghai Hengrui Pharmaceutical Co., Ltd.

Literature

Linked publications (28)

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

pubmedPublishedShowing 26–28 of 28 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

The impact of human EGFR kinase domain mutations on lung tumorigenesis and in vivo sensitivity to EGFR-targeted therapies.
· Cancer Cell · 2006 · PMID 16730237 · validated civic_curation pubmed
Afatinib is especially effective against non-small cell lung cancer carrying an EGFR exon 19 deletion.
· Anticancer Res · 2015 · PMID 25862853 · validated civic_curation pubmed
In vitro modeling to determine mutation specificity of EGFR tyrosine kinase inhibitors against clinically relevant EGFR mutants in non-small-cell lung cancer.
· Oncotarget · 2015 · PMID 26515464 · validated civic_curation pubmed

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

EGFR Exon 19 Deletion + EGFR L858R10

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

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

Amivantamab + Carboplatin + PemetrexedCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Amivantamab + LazertinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Dacomitinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Erlotinib + GefitinibSubstitutes

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Erlotinib + RamucirumabCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Gefitinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Osimertinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Chemotherapy + OsimertinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

EGFR C797S + EGFR Exon 19 Deletion + EGFR T790M1
Osimertinib	Lung Adenocarcinoma	Predictive	C	Supports Resistance	1	accepted	EID1396 Case report of a patient with stage IV lung adenocarcinoma and a 15–base pair deletion in EGFR exon 19. Partial response with erlotinib was achieved for 15 months after initial chemotherapy. After fur… (full text at CIViC) PMID 26181354 · Yu et al., 2015 · Open in CIViC	civic

EGFR C797S + EGFR Exon 19 Deletion + EGFR T790M1

Osimertinib

Lung Adenocarcinoma

Predictive

Supports Resistance

accepted

EID1396

Case report of a patient with stage IV lung adenocarcinoma and a 15–base pair deletion in EGFR exon 19. Partial response with erlotinib was achieved for 15 months after initial chemotherapy. After fur… (full text at CIViC)

PMID 26181354 · Yu et al., 2015 · Open in CIViC

EGFR Exon 19 Deletion + EGFR T790M2
Osimertinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	1	accepted	EID1397 Case report of a patient with stage IV lung adenocarcinoma and a 15–base pair deletion in EGFR exon 19. Partial response with erlotinib was achieved for 15 months after initial chemotherapy. After fur… (full text at CIViC) PMID 26181354 · Yu et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11598 This phase 3 trial (NCT02151981) involved 419 patients with EGFR T790M mutant NSCLC who progressed after first-line EGFR inhibitor therapy (gefitinib, erlotinib, or afatinib) and were either treated w… (full text at CIViC) PMID 27959700 · Mok et al., 2017 · Open in CIViC	civic

EGFR Exon 19 Deletion + EGFR T790M2

Osimertinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1397

PMID 26181354 · Yu et al., 2015 · Open in CIViC

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11598

This phase 3 trial (NCT02151981) involved 419 patients with EGFR T790M mutant NSCLC who progressed after first-line EGFR inhibitor therapy (gefitinib, erlotinib, or afatinib) and were either treated w… (full text at CIViC)

PMID 27959700 · Mok et al., 2017 · Open in CIViC

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Erlotinib	CA Health Canada	—	Marketed in Canada as NAT-ERLOTINIB (DIN 02483939) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Dec 1, 2021	May 8, 2019	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as NAT-ERLOTINIB (DIN 02483920) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Oct 1, 2021	May 8, 2019	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as NAT-ERLOTINIB (DIN 02483912) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince May 1, 2021	May 8, 2019	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as APO-ERLOTINIB (DIN 02461889) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 22, 2017	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as APO-ERLOTINIB (DIN 02461870) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 22, 2017	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as APO-ERLOTINIB (DIN 02461862) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 22, 2017	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as PMS-ERLOTINIB (DIN 02454394) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 28, 2016	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as PMS-ERLOTINIB (DIN 02454386) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 31, 2025	Jul 28, 2016	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as TEVA-ERLOTINIB (DIN 02377691) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 8, 2014	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as TEVA-ERLOTINIB (DIN 02377705) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 8, 2014	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as TEVA-ERLOTINIB (DIN 02377713) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 8, 2014	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as TARCEVA (DIN 02269007) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 1, 2024	Jan 5, 2007	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as TARCEVA (DIN 02269015) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 1, 2024	Jul 19, 2005	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as TARCEVA (DIN 02269023) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 1, 2024	Jul 19, 2005	health-canada-dpd
Erlotinib	EU EMA	—	Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.	approved	Sep 19, 2005	ema
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	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	—	Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.	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	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	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 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	CA Health Canada	—	Marketed in Canada as JAMP GEFITINIB (DIN 02500663) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 23, 2020	health-canada-dpd
Gefitinib	CA Health Canada	—	Marketed in Canada as NAT-GEFITINIB (DIN 02491796) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Mar 1, 2026	Nov 13, 2019	health-canada-dpd
Gefitinib	CA Health Canada	—	Marketed in Canada as SANDOZ GEFITINIB (DIN 02487748) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 31, 2026	Jun 26, 2019	health-canada-dpd
Gefitinib	CA Health Canada	—	Marketed in Canada as APO-GEFITINIB (DIN 02468050) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 18, 2017	health-canada-dpd
Gefitinib	CA Health Canada	—	Marketed in Canada as IRESSA (DIN 02248676) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 17, 2003	health-canada-dpd
Gefitinib	CA Health Canada	—	Marketed in Canada as AURO-GEFITINIB (DIN 02533685) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gefitinib	CA Health Canada	—	Marketed in Canada as EUGIA-GEFITINIB (DIN 02547546) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gefitinib	EU EMA	Lung Non-Small Cell Carcinoma	Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK.	withdrawnsince Sep 27, 2024	Sep 27, 2018	ema
Gefitinib	EU EMA	Lung Non-Small Cell Carcinoma	Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.	approved	Jun 24, 2009	ema
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	CA Health Canada	—	Marketed in Canada as LAZCLUZE (DIN 02555972) under ATC L01EB09 LAZERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 28, 2025	health-canada-dpd
Lazertinib	CA Health Canada	—	Marketed in Canada as LAZCLUZE (DIN 02555964) under ATC L01EB09 LAZERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 28, 2025	health-canada-dpd
Lazertinib	EU EMA	Lung Non-Small Cell Carcinoma	Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.	approved	Jan 20, 2025	ema
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	CA Health Canada	—	Marketed in Canada as TAGRISSO (DIN 02456222) under ATC L01EB04 OSIMERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 19, 2016	health-canada-dpd
Osimertinib	CA Health Canada	—	Marketed in Canada as TAGRISSO (DIN 02456214) under ATC L01EB04 OSIMERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 19, 2016	health-canada-dpd
Osimertinib	EU EMA	Lung Non-Small Cell Carcinoma	Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.accelerated	approved	Feb 1, 2016	ema
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

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

CA Health Canada

—

Marketed in Canada as NAT-ERLOTINIB (DIN 02483939) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Dec 1, 2021

May 8, 2019

CA Health Canada

—

Marketed in Canada as NAT-ERLOTINIB (DIN 02483920) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Oct 1, 2021

May 8, 2019

CA Health Canada

—

Marketed in Canada as NAT-ERLOTINIB (DIN 02483912) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince May 1, 2021

May 8, 2019

CA Health Canada

—

Marketed in Canada as APO-ERLOTINIB (DIN 02461889) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Aug 22, 2017

CA Health Canada

—

Marketed in Canada as APO-ERLOTINIB (DIN 02461870) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Aug 22, 2017

CA Health Canada

—

Marketed in Canada as APO-ERLOTINIB (DIN 02461862) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Aug 22, 2017

CA Health Canada

—

Marketed in Canada as PMS-ERLOTINIB (DIN 02454394) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jul 28, 2016

CA Health Canada

—

Marketed in Canada as PMS-ERLOTINIB (DIN 02454386) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Jul 31, 2025

Jul 28, 2016

CA Health Canada

—

Marketed in Canada as TEVA-ERLOTINIB (DIN 02377691) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Dec 8, 2014

CA Health Canada

—

Marketed in Canada as TEVA-ERLOTINIB (DIN 02377705) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Dec 8, 2014

CA Health Canada

—

Marketed in Canada as TEVA-ERLOTINIB (DIN 02377713) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Dec 8, 2014

CA Health Canada

—

Marketed in Canada as TARCEVA (DIN 02269007) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 1, 2024

Jan 5, 2007

CA Health Canada

—

Marketed in Canada as TARCEVA (DIN 02269015) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 1, 2024

Jul 19, 2005

CA Health Canada

—

Marketed in Canada as TARCEVA (DIN 02269023) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 1, 2024

Jul 19, 2005

EU EMA

—

Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

approved

Sep 19, 2005

ema