Drug · Small Molecule

Pemetrexed

CI-DRUG-00000466Explore in graph →NCIt C61614 CHEMBL225072 CIViC Approved

Regulatory

Approvals (102)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory50 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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
US FDA	Lung Non-Squamous Non-Small Cell Carcinoma

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	237	117	200	826	102	CA, EU, US	Feb 4, 2004	1997-09
Malignant Lung Neoplasm	Approved	Phase 4	174	84	163	550	33	US	Feb 4, 2004	2001-08
Malignant Mesothelioma	Approved	Phase 4	9	4	6	45	7	US	Feb 4, 2004	1999-11
Malignant Bladder Neoplasm	Phase3	Phase 3	2	1	1	5	0

Curated evidence

Clinical evidence (16)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–16 of 16 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
MTAP Deletion1
Pemetrexed	Bladder Urothelial Carcinoma

Clinical trials

Trials with this intervention (834)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 834 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
NCT03976323	Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)	completed	Phase 3	1,003	Merck Sharp & Dohme LLCINDUSTRY	20	Sep 28, 2026	clinicaltrials
NCT04988295	A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Molecule

Record

Kind: Small Molecule
Mechanism: Thymidylate synthase inhibitor; Dihydrofolate reductase inhibitor; GAR transformylase inhibitor
Targets: 3 genes
UNII: 9T47E4OM16
Aliases: ACT PEMETREXED, ALIMTA, Armisarte, AXTLE, Ciambra, L-Glutamic Acid, N-(4-(2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl), LY-231514, LY231514, MTA, Multitargeted Antifolate, NSC-698037, Pemetrexed, Pemetrexed Accord, Pemetrexed Baxter, PEMETREXED DIPOTASSIUM, Pemetrexed Disodium, PEMETREXED DISODIUM, Pemetrexed Disodium Hemipentahydrate, Pemetrexed Fresenius Kabi, Pemetrexed Krka, Pemetrexed Lilly, Pemetrexed medac, Pemetrexed Pfizer, Pemetrexed Sandoz, Pemfexy, PEMFEXY, PEMRYDI RTU, TARO-PEMETREXED

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (85)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01BA04	PEMETREXED
DIN (Health Canada)	02253437

EGFR Mutation2
Cisplatin + Pemetrexed + SintilimabCombination	Lung Carcinoma	Predictive	B	Supports Sensitivity Response	4	submitted	EID13098 In the randomized, double-blind phase III ORIENT-31 trial, patients with EGFR-mutated, nonsquamous non-small-cell lung cancer that had progressed following EGFR tyrosine kinase inhibitor therapy were … (full text at CIViC) PMID 37156249 · Lu et al., 2023 · Open in CIViC	civic
Gefitinib + PemetrexedCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID7650 A phase 2 study was conducted to compare treatment with pemetrexed and gefinitib (P+G) versus gefinitib monotherapy for a population of 195 East Asian non-squamous NSCLC patients with EGFR mutations (… (full text at CIViC) PMID 31605797 · Yang et al., 2020 · Open in CIViC	civic

EGFR Exon 19 Deletion + EGFR L858R2
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
Carboplatin OR Cisplatin + Pembrolizumab + PemetrexedCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Resistance	5	submitted	EID13097 In the randomized, double-blind phase III KEYNOTE-789 trial, 492 patients with EGFR exon 19 deletion- or L858R-positive, TKI-resistant metastatic nonsquamous non-small-cell lung cancer received pemetr… (full text at CIViC) PMID 39173098 · Yang et al., 2024 · Open in CIViC	civic

TYMS Overexpression2
Pemetrexed	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID832 mRNA expression of thymidylate synthase (TYMS) in 62 NSCLC patients correlated with response rate to pemetrexed mono- or combination therapy. Response rate with low TYMS expression was 0.29 compared w… (full text at CIViC) PMID 26502926 · Chamizo et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID922 mRNA levels of TYMS, DHFR and GARFT were assessed (rt-PCR) in 50 patient samples of NSCLC. TYMS mRNA levels were lower in responders compared to non-responders to pemetrexed (1.671 ± 0.844 versus 5.97… (full text at CIViC) PMID 23060591 · Shimizu et al., 2012 · Open in CIViC	civic

TYMS Underexpression2
Pemetrexed	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID907 49 tumor specimens from 268 NSCLC patients treated with pemetrexed were evaluated for expression of TYMS and DHFR by IHC and compared to treatment outcomes. Patients with low TS (≤150) expression had … (full text at CIViC) PMID 21367480 · Chen et al., 2011 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	C	Supports Sensitivity Response	2	accepted	EID908 Case report of a patient with metastatic prostate cancer and underexpression of TYMS who showed a nonspecified response to pemetrexed for at least 4 months. PMID 24782778 · Russell et al., 2014 · Open in CIViC	civic