GSK has received marketing authorization from the European Commission for trametinib as monotherapy for unresectable or metastatic melanoma in adults with a BRAF V600 mutation.
The European Commission has given marketing authorization for trametinib as monotherapy for unresectable or metastatic melanoma in adults with a mutation, GlaxoSmithKline announced.
Trametinib (Mekinist), a kinase inhibitor that targets / activation and kinase activity, has not demonstrated clinical activity in patients who have progressed on a prior inhibitor therapy. Before taking trametinib, patients must have confirmation of a mutation using a validated test.
The European Commission’s decision was based on results from the randomized, open-label phase 3 METRIC study of 322 patients with -mutant melanoma (types and ) who were either treatment-naïve or have received one prior chemotherapy treatment in the metastatic setting.
According to study results, treatment with trametinib resulted in a statistically significant increase in PFS compared to chemotherapy (HR= 0.45; 95% CI: 0.33, 0.63, <0.0001), with a median PFS of 4.8 months for patients taking trametinib (95% CI: 4.3, 4.9) vs. 1.5 months for chemotherapy (95% CI: 1.4, 2.7).
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