Patients with metastatic non-small cell lung cancer (NSCLC) that has an alteration in the BRAFgene called the V600E mutation can be treated with the FDA approved combination of dabrafenib (Tafinlar®) and trametinib (Mekinist®).
The approval is the first specifically for patients with this type of lung cancer, known as BRAF V600E mutation-positive metastatic NSCLC. About 1-2% of lung tumors harbor the V600E mutation, which increases growth-promoting signals through the MAPK signaling pathway.
FDA also approved the Oncomine™ Dx Target Test (included in our Century 55 panel) to determine the presence of the BRAF V600E mutation in patient samples. The test screens tumor samples for multiple biomarkers associated with potential responses to targeted therapies directed against these changes. These biomarkers include alterations in the BRAF, ALK, ROS1, and EGFR genes.
Dabrafenib and trametinib block different growth-promoting signals in the MAPK pathway that are activated by the V600E BRAF mutation. Dabrafenib inhibits the BRAF protein, whereas trametinib is a MEK inhibitor.
The introduction of genetic tests that can assess multiple biomarkers simultaneously has made it more efficient and cost effective to identify patients with rare subtypes of cancer who might be candidates for certain treatments.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564331.htm
