Rybrevant (amivantamab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Janssen-Cilag International N.V. Rybrevant (amivantamab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf. Revised July 2025. Accessed September 5, 2025.

View API

Regulatory approvals

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

Indication Statements
Rybrevant is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations. 1
Rybrevant is indicated as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based chemotherapy. 1
Rybrevant is indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). 4
Rybrevant is indicated in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) EGFR Exon 20 (Insertion) Non-Small Cell Lung Cancer Amivantamab, Carboplatin, Pemetrexed
Sensitivity (+) EGFR Exon 20 (Insertion) Non-Small Cell Lung Cancer Amivantamab
Sensitivity (+) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Amivantamab, Lazertinib
Sensitivity (+) EGFR p.L858R Non-Small Cell Lung Cancer Amivantamab, Lazertinib
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 19 (Deletion) Non-Small Cell Lung Cancer Amivantamab, Lazertinib
Sensitivity (+) EGFR p.L858R Non-Small Cell Lung Cancer Amivantamab, Lazertinib