Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug administration granted approval to amivantamab-vmjw in combination with carboplatin and pemetrexed for the 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, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

This is written in the approval document as:

RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

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, Carboplatin, Pemetrexed
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Carboplatin, Pemetrexed