Treats metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial…. Sold as Tepmetko. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Tepotinib Hydrochloride (sold as Tepmetko), first approved Feb 3, 2021, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Tepmetko | Part D | $65.5M | +62% | 661 |
| Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously TreatedAdvanced Non Small Cell Lung Cancer, MET Exon 14 Mutation · Intergroupe Francophone de Cancerologie Thoracique | Phase 3 | Recruiting | Apr 3, 2025 |
| POTENT - Tepotinib in Combination With Pembrolizumab in NSCLCAdvanced Cancer, Non Small Cell Lung Cancer · Institute of Cancer Research, United Kingdom | Phase 1 | Active, not recruiting | Mar 23, 2023 |
| The Drug Rediscovery Protocol (DRUP Trial)Cancer, Tumors · The Netherlands Cancer Institute | Phase 2 | Recruiting | Oct 5, 2016 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 3, 2021 | TepmetkoNDA 214096 · New molecular entity | Emd Serono Inc | 3 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
