Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR Exon 20 (Insertion) status confers therapeutic sensitivity to Amivantamab in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted approval to amivantamab-vmjw for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

This statement is based on a regulatory approval from the Food and Drug Administration:

RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

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. Janssen Biotech, Inc. Rybrevant (amivantamab-vmjw) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf. Revised March 2024. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-03-01	Food and Drug Administration	Indication received traditional approval.
2021-05-21	Food and Drug Administration	Indication received accelerated approval.