FDA approves Novartis' NSCLC combo

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved Tafinlar dabrafenib (GSK2118436) and Mekinist trametinib (GSK1120212) in combination to treat metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

FDA concurrently approved the Oncomine Dx Target Test from Thermo Fisher Scientific Inc. (NYSE:TMO) as a companion diagnostic for the combo to identify the BRAF V600E mutation. Oncomine Dx is also approved as a companion diagnostic for NSCLC drugs Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) and Iressa gefitinib from AstraZeneca plc (LSE:AZN; NYSE:AZN). Specifically, Oncomine Dx is indicated to identify tumors with c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1) fusions for Xalkori and EGFR mutations for Iressa. In the U.S., Xalkori is approved for anaplastic lymphoma kinase (ALK)- or ROS1-positive NSCLC and Iressa is approved for NSCLC patients with EGFR mutations. Thermo Fisher developed the test in collaboration with Novartis and Pfizer...