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 251–271 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
NCT06383728	Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma(GALAXY-02)	recruiting	Phase 2

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
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02459434) 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
Pemetrexed	CA Health Canada	—	Marketed in Canada as TARO-PEMETREXED (DIN 02429209) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 15, 2017	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as ALIMTA (DIN 02306433) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 29, 2026	Jan 9, 2009	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as ALIMTA (DIN 02253437) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 17, 2021	Aug 3, 2004	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02454610) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Aug 1, 2019	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02442833) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 30, 2024	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02441616) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Feb 28, 2022	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02554534) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED (DIN 02455528) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED (DIN 02455498) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02554542) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02454637) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Aug 1, 2019	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as ACT PEMETREXED (DIN 02428784) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 24, 2018	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as ACT PEMETREXED (DIN 02428776) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 24, 2018	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as ACT PEMETREXED (DIN 02428768) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 24, 2018	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02411024) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 30, 2024	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02534096) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02534088) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517655) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528762) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02411016) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 30, 2024	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02472619) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION USP (DIN 02482967) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02454629) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Aug 1, 2019	—	health-canada-dpd
Pemetrexed	EU EMA	—	Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). Pemetrexed Baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1). Pemetrexed Baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).	withdrawnsince May 2, 2025	Dec 9, 2022	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	withdrawn	May 22, 2018	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1).	withdrawn	Apr 24, 2017	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	approved	Jul 22, 2016	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Accord in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Accord is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Accord is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	approved	Jan 18, 2016	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	approved	Jan 18, 2016	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	withdrawnsince Oct 12, 2023	Dec 2, 2015	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	approved	Nov 26, 2015	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	approved	Nov 19, 2015	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	withdrawnsince Oct 9, 2024	Sep 18, 2015	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Lilly in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Lilly is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Lilly is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non small cell lung cancer other than predominantly squamous cell histology.	withdrawn	Sep 14, 2015	ema
Pemetrexed	EU EMA	—	Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma. Non-small-cell lung cancer Alimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology. Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.	approved	Sep 20, 2004	ema
Pemetrexed	US FDA	—	Efficacy supplement 2025-10-03 (see label)	approved	Oct 3, 2025	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	Jun 28, 2024	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	Jun 28, 2024	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	Jun 28, 2024	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	Jun 28, 2024	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	Jun 28, 2024	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
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	May 22, 2023	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	May 22, 2023	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	May 22, 2023	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	May 22, 2023	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: PEMRYDI RTU is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.	approved	May 22, 2023	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	May 22, 2023	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2022-12-14 (see label)	approved	Dec 14, 2022	openfda