Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR p.L858R status confers therapeutic sensitivity to Dacomitinib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to dacomitinib for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
This statement is based on a regulatory approval from the Food and Drug Administration:
VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.