Biomarker · Gene alteration

EGFR exon 19 deletion

In-frame deletions in EGFR exon 19 detected by sequencing or PCR; a sensitizing EGFR mutation used as a predictive marker for EGFR tyrosine kinase inhibitors in non-small cell lung cancer.

CI-BIO-00000009EGFR graph →NCIt C126892

Also calledex19del · EGFR del19 · exon 19 del

Derived

Associated cancers (2)

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	21	21	—	—	10 / 7 / 1 / 3 / 0
Lung Adenocarcinoma	10	10	—	—	0 / 7 / 3 / 0 / 0

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
ErlotinibSmall Molecule	8	8	—	A	8 / 0	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma
GefitinibSmall Molecule	8	8	—	A	8 / 0	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma

Curated evidence

Predictive evidence items (31)

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

civicCuratedShowing 1–31 of 31 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 Exon 19 Deletion18
Afatinib

Regulatory

Approvals mentioning the linked drugs (225)

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

ema

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

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

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

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

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

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

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

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

civic

Osimertinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11219

In this phase 3, double-blind trial, 682 patients were randomly assigned 1:1 to either osimertinib (80 mg once daily) or placebo for 3 years following complete resection of EGFR mutation positive (exo… (full text at CIViC)

PMID 32955177 · Wu et al., 2020 · Open in CIViC

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

civic

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

EGFR C797S + EGFR Exon 19 Deletion + EGFR T790M1

Osimertinib

Lung Adenocarcinoma

Predictive

Supports Resistance

accepted

EID1396

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

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

civic

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

EGFR Exon 19 Deletion + EGFR T790M2

Osimertinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1397

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

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

civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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 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	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	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	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	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-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	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	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	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	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	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 treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.	approved	May 22, 2023	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2022-12-14 (see label)	approved	Dec 14, 2022	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2022-11-22 (see label)	approved	Nov 22, 2022	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2022-11-22 (see label)	approved	Nov 22, 2022	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2022-11-22 (see label)	approved	Nov 22, 2022	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2022-08-31 (see label)	approved	Aug 31, 2022	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use : Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.	approved	Jun 22, 2022	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 22, 2022	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 22, 2022	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, non-small cell lung cancer (NSCLC).	approved	Jun 22, 2022	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 22, 2022	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 26, 2022	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 26, 2022	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.	approved	May 26, 2022	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 26, 2022	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 26, 2022	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 26, 2022	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.	approved	Aug 21, 2020	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	Aug 21, 2020	openfda
Pemetrexed	US FDA	—	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 epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.	approved	Aug 21, 2020	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	Aug 21, 2020	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	Aug 21, 2020	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	Aug 21, 2020	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 NSCLC, with no EGFR or ALK genomic tumor aberrations.	approved	Feb 8, 2020	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	Feb 8, 2020	openfda
Pemetrexed	US FDA	Lung Non-Small Cell Carcinoma	Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer.	approved	Feb 8, 2020	openfda
Pemetrexed	US FDA	Pleural Malignant Mesothelioma	in combination with cisplatin for the initial treatment, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.	approved	Feb 8, 2020	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	Feb 8, 2020	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, non-small cell lung cancer (NSCLC).	approved	Feb 8, 2020	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2019-01-30 (see label)	approved	Jan 30, 2019	openfda
Pemetrexed	US FDA	—	Efficacy supplement 2018-06-04 (see label)	approved	Jun 4, 2018	openfda

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