• Dabrafenib and trametidnib (Tafinlar and Mekinist) received FDA approval for use in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAFV600E mutation as detected by an FDAapproved test. This is the first FDA approval specifically for treatment of patients with BRAFV600E mutationpositive metastatic NSCLC. (6/22/17)
• The FDA also approved the first multiple companion diagnostics nextgeneration sequencing (NGS)-based test (Oncomine Dx Target Test) to detect single gene mutations and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin- fixed, paraffin-embedded tumor tissue samples from patients with NSCLC. This test is currently indicated to aid in selecting NSCLC patients for treatment with combination dabrafenib and trametinib, gefitinib, or crizotinib for BRAF and EGFR mutations and ROS1 fusions, respectively. With this test, physicians can now match patients to these therapies in days instead of several weeks, which often occurs when screening samples one biomarker at a time. (6/22/17)
• Ceritinib (Zykadia) received European Commission approval for use in first-line treatment of patients with advanced NSCLC whose tumors are ALK-positive. This approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP), and is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway. (6/29/17)
