Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that EGFR p.L858R status confers therapeutic sensitivity to Amivantamab, Carboplatin, Pemetrexed in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the Health Canada:

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.