Overview
Tepotinib is a MET tyrosine kinase inhibitor intended to treat a variety of MET-overexpressing solid tumors. It was originally developed in partnership between EMD Serono and the University of Texas M.D. Anderson Cancer Center in 2009 and has since been investigated in the treatment of neuroblastoma, gastric cancers, non-small cell lung cancer, and hepatocellular carcinoma. MET is a desirable target in the treatment of certain solid tumors as it appears to play a critical role, both directly and indirectly, in the growth and proliferation of tumors in which it is overexpressed and/or mutated. Tepotinib was first approved in Japan in March 2020 for the treatment of non-small cell lung cancers (NSCLC) with MET alterations, and was subsequently granted accelerated approval by the US FDA in February 2021, under the brand name Tepmetko, for the treatment of adult patients with metastatic NSCLC and MET exon 14 skipping alterations. It is the first oral MET-targeted tyrosine kinase inhibitor to allow for once-daily dosing, an advantage that may aid in easing the pill burden often associated with chemotherapeutic regimens. In February 2022, tepotinib was approved for use in Europe.
Indication
Tepotinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/03 | Phase 3 | Not yet recruiting | Intergroupe Francophone de Cancerologie Thoracique | ||
2023/10/30 | Phase 2 | Not yet recruiting | |||
2023/10/16 | Phase 1 | Active, not recruiting | |||
2023/09/11 | Phase 2 | Recruiting | |||
2023/03/23 | Phase 1 | Recruiting | Institute of Cancer Research, United Kingdom | ||
2022/06/30 | Phase 1 | Recruiting | |||
2022/01/28 | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | ||
2022/01/24 | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | ||
2021/12/16 | Phase 2 | Recruiting | |||
2021/11/16 | Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| EMD Serono, Inc. | 44087-5000 | ORAL | 225 mg in 1 1 | 2/23/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/16/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TEPMETKO FILM-COATED TABLET 225MG | SIN16386P | TABLET, FILM COATED | 225mg | 11/25/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tepotinib Hydrochloride Tablets | 国药准字HJ20230132 | 化学药品 | 片剂 | 12/5/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack | 370977 | Medicine | A | 1/17/2022 |
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