Mekinist® is the commercial brand name of Trametinib Tablets, developed by Novartis. It is an oral selective MEK1/MEK2 inhibitor. It blocks downstream MEK signaling of the RAS-RAF-MEK-ERK pathway, inhibiting proliferation of tumor cells carrying BRAF V600 mutations.
Main Indications
Combined therapy with dabrafenib for unresectable or metastatic BRAF V600-mutant melanoma in adults;
Combined treatment with dabrafenib for BRAF V600 mutation-positive advanced non-small cell lung cancer in adults;
Adjuvant combination therapy with dabrafenib for stage III BRAF V600-mutant melanoma after complete surgical resection.
Clinical Research
Global multicenter phase III pivotal trials fully validated the durable anti-tumor efficacy of trametinib plus dabrafenib combination for BRAF-mutant advanced melanoma;
Head-to-head registration trials confirmed longer progression-free survival and lower resistance incidence compared with single-agent BRAF inhibitors;
Long-term postoperative adjuvant cohort studies demonstrated significant reduction of melanoma recurrence risk in stage III mutant patients;
Dose-finding research verified balanced anti-tumor activity and cutaneous safety profile of the 2mg once-daily oral regimen;
Chinese domestic registration trials confirmed consistent therapeutic efficacy and manageable adverse reactions for local BRAF-mutant tumor populations.
Common Side Effects
Common mild adverse reactions: Rash, dry skin, diarrhea, fatigue, peripheral edema and headache;
Laboratory abnormalities: Transient mild liver enzyme elevation, elevated creatine phosphokinase and hypoalbuminemia;
Severe but uncommon risks: Severe cutaneous toxicity, interstitial lung disease, ocular retinal lesions, cardiomyopathy and severe hemorrhage.
Approval Status in China
Original drug Mekinist® was officially approved for marketing in China in 2019, with the specification of 2mg per tablet, 30 tablets per bottle. It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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