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.

This statement is based on a regulatory approval from the European Medicines Agency:

Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Citation

Janssen Cilag International NV. Lazcluze (lazertinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf. Revised January 2025. Accessed September 8, 2025.