Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Amivantamab, Lazertinib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to amivantamab-vmjw in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions 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:
LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.