The US Food and Drug Administration has granted drugmaker Novartis (NOVN: VX) approval to market Tafinlar (dabrafenib) and Mekinist (trametinib) as a combination therapy for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation.
It's the first FDA approval for a therapy aimed specifically at treating patients with BRAF V600E mutation-positive metastatic NSCLC.
The Swiss pharmaceutical giant received marketing authorization for this indication in the European Union a few months ago.
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