Novartis' Tafinlar + Mekinist Combo Wins FDA Okay for BRAF V600E-Mutant NSCLC

05:20 EDT 23 Jun 2017 | Genetic Engineering News

FDA approved Novartis’ BRAF inhibitor Tafinlar® (dabrafenib) and MEK1/2 inhibitor Mekinist® (trametinib) as combination therapy for patients with BRAF V600E mutated metastatic non-small cell lung cancer (NSCLC). Novartis said the clearance marks the first in the U.S. for a targeted therapy specifically for metastatic NSCLC with BRAF V600E mutations.The drug combination was cleared by the EC in March for the treating patients with BRAF V600 advanced mutation-positive NSCLC.  The treatment combination is approved for use alongside Thermo Fisher Scientific's companion diagnostic Oncomine™ Dx Target Test to identify eligible patients with BRAF V600-mutated tumors. The Oncomine Dx Target Test was separately granted FDA 510(k) clearance today . NSCLC patients with the BRAF V600E mutation have typically responded less well to standard chemotherapy, commented Bruno Strigini, Novartis Oncology CEO. "Today's approval of the Tafinlar + Mekinist combination validates our expertise in tumor biology, which enabled us to develop the ...

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