The FDA on June 22, 2017 granted regular approvals to TAFINLAR® and MEKINIST® administered in combination for patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Inc. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.
The FDA today also approved the Oncomine™ Dx Target Test (Thermo Fisher Scientific), a Next Generation Sequencing (NGS) test to detect multiple gene mutations for lung cancer in a single test from a single tissue specimen. This test detects the presence of BRAF, ROS1, and EGFR gene mutations or alterations in tumor tissue of patients with NSCLC. This test can be used to select patients with NSCLC with the BRAF V600E mutation for treatment with the combination of TAFINLAR® and MEKINIST®. This is the first NGS oncology panel test approved by the FDA for multiple companion diagnostic indications.