EGFR T790M — biomarker · CancerIndex

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

health-canada-dpd

Clinical trials

Active trials (271)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 124 recruiting · 91 active phase 3 · 1,127 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 101–150 of 271 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
NCT04166487	Plasma-Adapted First-Line Pembro In NSCLC	active not recruiting	Phase 2	40	Julia K. Rotow, MD

Literature

Linked publications (32)

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

pubmedPublishedShowing 26–32 of 32 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer.
· Cancer Discov · 2014 · PMID 24893891 · validated civic_curation pubmed
PF00299804, an irreversible pan-ERBB inhibitor, is effective in lung cancer models with EGFR and ERBB2 mutations that are resistant to gefitinib.
· Cancer Res · 2007 · PMID 18089823 · validated civic_curation pubmed
Non-small-cell lung cancer and Ba/F3 transformed cells harboring the ERBB2 G776insV_G/C mutation are sensitive to the dual-specific epidermal growth factor receptor and ERBB2 inhibitor HKI-272.
· Cancer Res · 2006 · PMID 16818618 · validated civic_curation pubmed
Development of new mouse lung tumor models expressing EGFR T790M mutants associated with clinical resistance to kinase inhibitors.

EGFR T790M + EGFR Fusion1
Icotinib	Lung Adenocarcinoma	Predictive	C	Supports Resistance	2	accepted	EID10895 A patient was initially diagnosed with stage IIIA lung adenocarcinoma with EGFR L858R and was treated with lobectomy and adjuvant pemetrexed and cisplatin. 20 months later the patient had recurrent di… (full text at CIViC) PMID 35004270 · Wang et al., 2021 · Open in CIViC	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 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 del + EGFR T790M1
Osimertinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID12946 A 53-year-old Chinese man, a lifelong non-smoker, presented with chest tightness and pain. CT imaging revealed multiple small nodules in the right lower lobe of the lung. A biopsy confirmed stage IV l… (full text at CIViC) PMID 38074875 · Xiang et al., 2023 · Open in CIViC	civic

EGFR L858R + EGFR T790M1
Osimertinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11599 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
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	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	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
Lapatinib	CA Health Canada	—	Marketed in Canada as TYKERB (DIN 02326442) under ATC L01EH01 LAPATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 5, 2009	health-canada-dpd
Lapatinib	EU EMA	Malignant Breast Neoplasm	Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.	approved	Jun 10, 2008	ema
Lapatinib	US FDA	—	Efficacy supplement 2018-12-06 (see label)	approved	Dec 6, 2018	openfda
Lapatinib	US FDA	—	Efficacy supplement 2013-10-18 (see label)	approved	Oct 18, 2013	openfda
Lapatinib	US FDA	—	Efficacy supplement 2013-10-18 (see label)	approved	Oct 18, 2013	openfda
Lapatinib	US FDA	—	Efficacy supplement 2010-01-29 (see label)	approved	Jan 29, 2010	openfda
Lapatinib	US FDA	Malignant Breast Neoplasm	TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.	approved	Mar 13, 2007	openfda
Neratinib	CA Health Canada	—	Marketed in Canada as NERLYNX (DIN 02490536) under ATC L01EH02 NERATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 20, 2019	health-canada-dpd
Neratinib	EU EMA	Malignant Breast Neoplasm	Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.	approved	Aug 31, 2018	ema
Neratinib	US FDA	—	Efficacy supplement 2021-06-28 (see label)	approved	Jun 28, 2021	openfda
Neratinib	US FDA	—	Efficacy supplement 2020-07-29 (see label)	approved	Jul 29, 2020	openfda
Neratinib	US FDA	—	Efficacy supplement 2020-02-25 (see label)	approved	Feb 25, 2020	openfda
Neratinib	US FDA	—	Efficacy supplement 2020-02-25 (see label)	approved	Feb 25, 2020	openfda
Neratinib	US FDA	—	Efficacy supplement 2019-10-01 (see label)	approved	Oct 1, 2019	openfda
Neratinib	US FDA	HER2-Positive Breast Carcinoma	In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.	approved	Jul 17, 2017	openfda
Neratinib	US FDA	HER2-Positive Breast Carcinoma	As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.	approved	Jul 17, 2017	openfda
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	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	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
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	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	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 Mesylate	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
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528754) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 8, 2024	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528746) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 8, 2024	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517639) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 15, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517647) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 15, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED FOR INJECTION, USP (DIN 02463091) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 17, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED FOR INJECTION, USP (DIN 02463083) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 17, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED FOR INJECTION (DIN 02515423) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 10, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as TARO-PEMETREXED (DIN 02480492) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 7, 2021	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as TARO-PEMETREXED (DIN 02429195) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 18, 2018	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02438682) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 29, 2017	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02438674) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 24, 2017	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02394227) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 31, 2017	health-canada-dpd