Treats metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial…. NDA 214096, held by Emd Serono Inc. Tepotinib Hydrochloride.
As of Nov 13, 2026, NDA 214096 (Tepmetko), held by Emd Serono Inc, was first approved by FDA on Feb 3, 2021, with 3 approved supplements and 0 published complete response letters.
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
| Feb 15, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 3, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TepmetkoEQ 225MG BASE · tablet;oral | Tepotinib Hydrochloride | RxReference drug |
| Feb 15, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Mar 23, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Feb 3, 2021 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
