Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR p.L858R 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 lazertinib 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.

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.

Citation

Janssen Biotech, Inc. Lazcluze (lazertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf. Revised August 2024. Accessed October 30, 2024. Janssen Biotech, Inc. Lazcluze (lazertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf. Revised August 2024. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-08-19	Food and Drug Administration	Indication received traditional approval.