Health Canada conditionally approves Tabrecta for locally advanced unresectable or metastatic non-small cell lung cancer.- Novartis
Novartis Pharmaceuticals Canada Inc. announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) for Tabrecta (capmatinib tablets) for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Efficacy and safety results of Tabrecta were based on the pivotal phase II, single-arm study A2201 (GEOMETRY mono-1) conducted in adult patients with treatment-naive or previously treated, locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC with MET dysregulation, with overall response rate and duration of response as primary and key secondary endpoints, respectively. Documentation of the presence of a MET exon 14 (METex14) alteration based on a validated test is required prior to treatment with Tabrecta.
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