Biomarker · Gene alteration

EGFR T790M

EGFR exon 20 point mutation p.T790M detected in tumor tissue or plasma; an acquired resistance mutation to earlier-generation EGFR inhibitors used as a predictive marker for third-generation agents.

CI-BIO-00000011EGFR graph →NCIt C98503

Also calledp.T790M · gatekeeper mutation · c.2369C>T

Derived

Associated cancers (5)

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	27	25	2	—	5 / 10 / 2 / 9 / 1
Lung Adenocarcinoma	6	6	—	—	0 / 1 / 5 / 0 / 0
Malignant Lung Neoplasm	1	1	—	—	0 / 0 / 0 / 1 / 0
Malignant Neoplasm	1	1	—	—	0 / 0 / 0 / 1 / 0
Pancreatic Adenocarcinoma

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
OsimertinibSmall Molecule	13	12	1	A	11 / 1	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Pancreatic Adenocarcinoma
GefitinibSmall Molecule	7	—	7	B	0 / 7

Curated evidence

Predictive evidence items (34)

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

civicCuratedShowing 1–34 of 34 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 T790M28
Erlotinib +

Regulatory

Approvals mentioning the linked drugs (190)

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 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

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Afatinib	CA Health Canada	—	Marketed in Canada as MAR-AFATINIB (DIN 02517019) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 31, 2025	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as MAR-AFATINIB (DIN 02517035) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 31, 2025	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as MAR-AFATINIB (DIN 02517027) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 31, 2025	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as SANDOZ AFATINIB (DIN 02512777) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2024	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as SANDOZ AFATINIB (DIN 02512793) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2024	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as SANDOZ AFATINIB (DIN 02512785) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2024	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as GIOTRIF (DIN 02415682) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 17, 2014	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as GIOTRIF (DIN 02415674) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 17, 2014	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as GIOTRIF (DIN 02415666) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 17, 2014	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as TEVA-AFATINIB (DIN 02514605) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025	—	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as TEVA-AFATINIB (DIN 02514591) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025	—	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as TEVA-AFATINIB (DIN 02514613) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025	—	health-canada-dpd
Afatinib	EU EMA	Lung Non-Small Cell Carcinoma	Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.	approved	Sep 25, 2013	ema
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	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
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
Aumolertinib	EU EMA	Lung Non-Small Cell Carcinoma	Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)	approved	Feb 12, 2026	ema
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	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 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 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 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 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 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 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 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 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 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 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	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	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	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
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

Associated cancers (5)

Drugs with predictive evidence (13)

Predictive evidence items (34)

Approvals mentioning the linked drugs (190)

Active trials (270)

Linked publications (32)