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 European Medicines Agency (EMA) has authorized lazertinib 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.

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.

Contributions

Date	Contributor	Description
2025-09-08	Van Allen lab	On 2025-03-17, the EMA provided approval to Lazcluze (lazertinib) for the therapeutic indication of lazertinib 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.
2025-01-20	European Medicines Agency	Indication received approval from the European Commission.