Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Amivantamab, Lazertinib
FDA (1) EGFR p.L858R Non-Small Cell Lung Cancer Amivantamab, Lazertinib