Rybrevant (amivantamab-vmjw) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
RYBREVANT (amivantamab for injection) is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic NSCLC with activating EGFR Exon 20 insertion mutations.	1
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
Sensitivity (+)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab, Carboplatin, Pemetrexed
Sensitivity (+)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab