Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Citation

Janssen Biotech, Inc. Rybrevant (amivantamab-vmjw) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf. Revised September 2024. Accessed October 30, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib