Regulatory approval

Published by the Health Canada.

Health Canada approved amivantamab in combination with carboplatin and pemetrexed for the treatment of 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 osimertinib.

This is written in the approval document as:

RYBREVANT (amivantamab for injection) is indicated in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal-growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.

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