Drug · Small Molecule

Tepotinib

CI-DRUG-00000585Explore in graph →NCIt C88314 CHEMBL3402762 CIViC Approved

Regulatory

Approvals (4)

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

health-canada-dpdRegulatory4 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as TEPMETKO (DIN 02516322) under ATC L01EP02 TEPOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 7, 2021	health-canada-dpd
EU EMA	Lung Non-Small Cell Carcinoma	Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.	approved	Feb 16, 2022	ema
US FDA	—	Efficacy supplement 2024-02-15 (see label)	approved	Feb 15, 2024	openfda
US

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 14 days 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 3	9	6	1	22	4	CA, EU, US	Feb 3, 2021	Nov 30, 2009
Malignant Lung Neoplasm	Approved	Phase 3	5	3	1	9	2	EU, US	Feb 3, 2021	Dec 23, 2013
Malignant Breast Neoplasm	Phase2	Phase 2	0	0	0	1	0	—	—	Oct 7, 2020
Malignant Liver Neoplasm	Phase2	Phase 2	0	0	0	2	0

Curated evidence

Clinical evidence (15)

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

civicCuratedShowing 1–15 of 15 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 L858R + EGFR T790M + MET Exon 14 Skipping MutationEGFR MET

Clinical trials

Trials with this intervention (22)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–22 of 22 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
NCT07619339	A Study of Tepotinib and Ivonescimab in People With Non-Small Cell Lung Cancer	recruiting	Phase 1	16	Memorial Sloan Kettering Cancer CenterOTHER	1	Sep 16, 2026	clinicaltrials
NCT06083857	PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer	active not recruiting	Phase 1 / Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Hepatocyte growth factor receptor inhibitor
Targets: 1 gene
UNII: VY5YX2TQ1F
Aliases: Benzonitrile, 3-(1,6-Dihydro-1-((3-(5-((1-methyl-4-piperidinyl)methoxy)-2-pyrimidinyl)phenyl)methyl)-6-oxo-3-pyridazinyl)-, C-Met Inhibitor MSC2156119J, EMD 1214063, EMD1214063, MSC 2156119, MSC-2156119, MSC2156119, MSC 2156119J, MSC-2156119J, MSC2156119J, TEPMETKO, Tepotinib, Tepotinib Hydrochloride

Data updated 23 hours agoSource updated unknown

Identifiers

Codes (5)

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

System	Code	Label
ATC (WHO)	L01EP02	TEPOTINIB
ATC (WHO)	L01EX21	Antineoplastic agents

MET Exon 14 Skipping Mutation8
Tepotinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID11464 A 75-year old woman presented with lung adenocarcinoma (stage IVA) to which next-generation sequencing revealed METex14del. The patient was put on crizotinib (500 mg/day) and showed partial response f… (full text at CIViC) PMID 33533182 · Takamori et al., 2021 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	4	submitted	EID11465 A 56-year old male (smoker: 50 pack-years) was diagnosed with stage IIIA lung adenocarcinoma. Patient underwent four cycles of cisplatin and pemetrexed and maintenance therapy with pemetrexed but was … (full text at CIViC) PMID 33387444 · Tanaka et al., 2021 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11476 A 57-year female (non-smoker) was diagnosed with lung adenocarcinoma via pleural fluid cytology. After multigene testing revealed MET exon 14 skipping mutation, the patient was switched from cisplatin… (full text at CIViC) PMID 36810936 · Ikeo et al., 2023 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID11477 A 60-year old male (smoker: 38 pack-years presented with stage IIB lung adenocarcinoma. After receiving an upper lobectomy, the left lobar lymph node was pathologically positive and received cisplati… (full text at CIViC) PMID 37228358 · Onodera et al., 2023 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	submitted	EID8848 In this open-label phase 2 trial, MET inhibitor tepotinib was administered to patients with non-small cell lung cancer and MET exon 14 skipping mutation found in either liquid and/or tissue biopsy. A … (full text at CIViC) PMID 32469185 · Paik et al., 2020 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	submitted	EID11766 In the VISION phase 2 trial (NCT02864992), 313 patients with advanced, metastatic non-small cell lung cancer harboring MET exon 14 skipping mutations were treated with 500 mg/kg tepotinib daily. In t… (full text at CIViC) PMID 37270698 · Mazieres et al., 2023 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID7272 In a interim analysis of Phase II trial for MET exon 14 skipping NSCLC, 34 patients received MEK selective inhibitor tepotinib. 9/15 (60.0%) evaluable patients had a confirmed PR and 3 (20.0%) had SD.… (full text at CIViC) Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	submitted	EID11415 An 84-year old man (smoker: 62-pack-years) was diagnosed with stage IVB non-small-cell lung cancer (NSCLC) and was started on carboplatin and nab-paclitaxel. After the tumor progressed, the patient wa… (full text at CIViC) PMID 35383870 · Tanaka et al., 2022 · Open in CIViC	civic

MET Exon 14 Skipping Mutation8

Tepotinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11464

A 75-year old woman presented with lung adenocarcinoma (stage IVA) to which next-generation sequencing revealed METex14del. The patient was put on crizotinib (500 mg/day) and showed partial response f… (full text at CIViC)

PMID 33533182 · Takamori et al., 2021 · Open in CIViC

civic

〃

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11465

A 56-year old male (smoker: 50 pack-years) was diagnosed with stage IIIA lung adenocarcinoma. Patient underwent four cycles of cisplatin and pemetrexed and maintenance therapy with pemetrexed but was … (full text at CIViC)

PMID 33387444 · Tanaka et al., 2021 · Open in CIViC

civic

〃

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11476

A 57-year female (non-smoker) was diagnosed with lung adenocarcinoma via pleural fluid cytology. After multigene testing revealed MET exon 14 skipping mutation, the patient was switched from cisplatin… (full text at CIViC)

PMID 36810936 · Ikeo et al., 2023 · Open in CIViC

civic

〃

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11477

A 60-year old male (smoker: 38 pack-years presented with stage IIB lung adenocarcinoma. After receiving an upper lobectomy, the left lobar lymph node was pathologically positive and received cisplati… (full text at CIViC)

PMID 37228358 · Onodera et al., 2023 · Open in CIViC

civic

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID8848

In this open-label phase 2 trial, MET inhibitor tepotinib was administered to patients with non-small cell lung cancer and MET exon 14 skipping mutation found in either liquid and/or tissue biopsy. A … (full text at CIViC)

PMID 32469185 · Paik et al., 2020 · Open in CIViC

civic

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID11766

In the VISION phase 2 trial (NCT02864992), 313 patients with advanced, metastatic non-small cell lung cancer harboring MET exon 14 skipping mutations were treated with 500 mg/kg tepotinib daily. In t… (full text at CIViC)

PMID 37270698 · Mazieres et al., 2023 · Open in CIViC

civic

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7272

In a interim analysis of Phase II trial for MET exon 14 skipping NSCLC, 34 patients received MEK selective inhibitor tepotinib. 9/15 (60.0%) evaluable patients had a confirmed PR and 3 (20.0%) had SD.… (full text at CIViC)

Open in CIViC

civic

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID11415

An 84-year old man (smoker: 62-pack-years) was diagnosed with stage IVB non-small-cell lung cancer (NSCLC) and was started on carboplatin and nab-paclitaxel. After the tumor progressed, the patient wa… (full text at CIViC)

PMID 35383870 · Tanaka et al., 2022 · Open in CIViC

civic

CD274 Overexpression + MET Exon 14 Skipping MutationCD274 MET3
Tepotinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11460 A 75-year old female (non-smoker) was diagnosed with stage IVA lung adenocarcinoma harboring PD-L1 overexpression (tumor proportion score = 90%). After preliminary treatments became resistant and were… (full text at CIViC) PMID 35252894 · Hashiguchi et al., 2022 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	4	submitted	EID11463 A 77-year old woman presented with metastatic lung adenocarcinoma with MET exon 14 skipping mutation and PD-L1 tumor proportion score of 90%. Pembrolizumab was given but progressed after 1 year. Lepto… (full text at CIViC) PMID 34590003 · Ninomaru et al., 2021 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11695 A 86-year old male (former smoker) presented to the hospital after an accidental fall. PET/CT confirmed lung adenocarcinoma with sarcomatoid transformation. Immunohistochemical evaluation and next-gen… (full text at CIViC) PMID 37840886 · Inno et al., 2023 · Open in CIViC	civic

CD274 Overexpression + MET Exon 14 Skipping MutationCD274 MET3

Tepotinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11460

A 75-year old female (non-smoker) was diagnosed with stage IVA lung adenocarcinoma harboring PD-L1 overexpression (tumor proportion score = 90%). After preliminary treatments became resistant and were… (full text at CIViC)

PMID 35252894 · Hashiguchi et al., 2022 · Open in CIViC

civic

〃

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11463

A 77-year old woman presented with metastatic lung adenocarcinoma with MET exon 14 skipping mutation and PD-L1 tumor proportion score of 90%. Pembrolizumab was given but progressed after 1 year. Lepto… (full text at CIViC)

PMID 34590003 · Ninomaru et al., 2021 · Open in CIViC

civic

〃

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11695

A 86-year old male (former smoker) presented to the hospital after an accidental fall. PET/CT confirmed lung adenocarcinoma with sarcomatoid transformation. Immunohistochemical evaluation and next-gen… (full text at CIViC)

PMID 37840886 · Inno et al., 2023 · Open in CIViC

civic

MET Splice Site (c.3028+2T>C)1
Capmatinib + TepotinibSubstitutes	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID11412 A 72-year old man (non-smoker) was diagnosed with lung adenocarcinoma and developed multiple recurring brain and lung metastases. Systemic chemotherapy was administered, and genomic analysis of the su… (full text at CIViC) PMID 34695875 · Kunimasa et al., 2021 · Open in CIViC	civic

MET Splice Site (c.3028+2T>C)1

Capmatinib + TepotinibSubstitutes

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

submitted

EID11412

A 72-year old man (non-smoker) was diagnosed with lung adenocarcinoma and developed multiple recurring brain and lung metastases. Systemic chemotherapy was administered, and genomic analysis of the su… (full text at CIViC)

PMID 34695875 · Kunimasa et al., 2021 · Open in CIViC

civic

EGFR Mutation + MET Amplification + MET OverexpressionMET EGFR1
Gefitinib + TepotinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	submitted	EID11456 This phase 1b/2, multicentre, randomized clinical trial was conducted on the combination of tepotinib and gefitinib on patients with MET overexpression or MET amplification that showed resistance to E… (full text at CIViC) PMID 32479794 · Wu et al., 2020 · Open in CIViC	civic

EGFR Mutation + MET Amplification + MET OverexpressionMET EGFR1

Gefitinib + TepotinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID11456

This phase 1b/2, multicentre, randomized clinical trial was conducted on the combination of tepotinib and gefitinib on patients with MET overexpression or MET amplification that showed resistance to E… (full text at CIViC)

PMID 32479794 · Wu et al., 2020 · Open in CIViC

civic

MET H1094L1
Tepotinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	submitted	EID7958 Mouse xenograft models using NIH3T3 cells stably expressing MET H1112L were established to test the efficiency of the MET inhibitor EMD1214063 (Tepotinib). The MET H1112L xenograft tumours showed comp… (full text at CIViC) PMID 24061647 · Medová et al., 2013 · Open in CIViC	civic

MET H1094L1

Tepotinib

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

submitted

EID7958

Mouse xenograft models using NIH3T3 cells stably expressing MET H1112L were established to test the efficiency of the MET inhibitor EMD1214063 (Tepotinib). The MET H1112L xenograft tumours showed comp… (full text at CIViC)

PMID 24061647 · Medová et al., 2013 · Open in CIViC

civic