TEPMETKO® is the official global commercial brand name, and Tuodekang is its Chinese brand name developed by Merck. It is an oral highly selective MET tyrosine kinase inhibitor. It blocks MET receptor signaling cascade, inhibiting proliferation and metastasis of non-small cell lung cancer driven by MET exon 14 skipping mutation.
Main Indications
Monotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation.
Clinical Research
Global multicenter VISION phase II pivotal trials fully validated its durable anti-tumor efficacy and intracranial activity for METex14-mutant NSCLC in both treatment-naive and pretreated patients;
Head-to-head cohort comparative analysis confirmed sustained tumor remission and prolonged disease control duration versus traditional chemotherapy;
Long-term open-label extension follow-up demonstrated stable long-term survival benefit under continuous once-daily oral administration;
Dose-finding research verified balanced anti-tumor activity and liver safety profile of the 450mg once-daily standard regimen;
Chinese domestic registration trials confirmed consistent therapeutic efficacy and controllable adverse reaction spectrum for local MET exon 14-mutant NSCLC populations.
Common Side Effects
Common mild adverse reactions: Peripheral edema, fatigue, nausea, diarrhea, elevated liver enzymes and hypoalbuminemia;
Laboratory abnormalities: Transient ALT/AST elevation, decreased albumin and elevated blood creatinine;
Severe but uncommon risks: Severe hepatotoxicity, interstitial lung disease/pneumonitis, massive peripheral edema and secondary infection.
Approval Status in China
Original drug TEPMETKO® (Chinese brand: Tuodekang) was officially approved for marketing in China in 2022, with the specification of 225mg per tablet, 60 tablets per box. It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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