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 1–50 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
NCT04267848	Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])	recruiting	Phase 3

Literature

Linked publications (28)

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

pubmedPublishedShowing 1–25 of 28 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.
· N Engl J Med · 2017 · PMID 27959700 · validated civic_curation pubmed
U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.
· Oncologist · 2014 · PMID 24868098 · validated civic_curation pubmed
Afatinib: first global approval.
· Drugs · 2013 · PMID 23982599 · validated civic_curation pubmed
Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer.
· N Engl J Med · 2020 · PMID 32955177 · validated

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

Erlotinib

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

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

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

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
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib	US FDA	Lung Non-Small Cell Carcinoma	in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Osimertinib Mesylate	US FDA	Lung Non-Small Cell Carcinoma	adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.	approved	Nov 13, 2015	openfda
Pemetrexed	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 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 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
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 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 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 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 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	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 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 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 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 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 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 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 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 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 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 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	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).	approved	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 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

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

US FDA

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

US FDA

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

US FDA

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

US FDA

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

US FDA

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

US FDA

approved

Nov 13, 2015

US FDA

approved

Nov 13, 2015

US FDA

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

US FDA