Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Binimetinib, Encorafenib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to binimetinib in combination with encorafenib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
This statement is based on a regulatory approval from the Food and Drug Administration:
BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.