Tepmetko FDA Approval History
Last updated by Judith Stewart, BPharm on March 4, 2021.
Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
- This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Tepmetko is indicated for use in adult patients whose tumors have an abnormal mesenchymal epithelial transition (MET) gene as detected by an FDA approved test.
- Tepmetko is taken once daily with food until disease progression or unacceptable toxicity.
- Patients taking Tepmetko should be warned of the increased risk of severe or fatal interstitial lung disease/pneumonitis, hepatotoxicity, and the potential risk of embryo-fetal toxicity requiring the use of effective contraception during and shortly after treatment.
- Common adverse reactions include edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.
Development timeline for Tepmetko
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