Regulatory approval

Published by the Health Canada.

Health Canada approved amivantamab as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

This is written in the approval document as:

RYBREVANT (amivantamab for injection) is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Citation

Janssen Inc. Rybrevant (amivantamab-vmjw) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078295.PDF. Revised January 2025. Accessed June 2025.

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) EGFR Exon 20 (Insertion) Non-Small Cell Lung Cancer Amivantamab