# Amivantamab

Amivantamab (Rybrevant) has 4 EU-approved indications in 1 tumour type. Each needs a biomarker result: EGFR (4).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EGFR exon 20 insertion | + carboplatin and pemetrexed | 1st line, advanced | - |
| EGFR exon 19 deletions or exon 21 L858R | + lazertinib | 1st line, advanced | - |
| EGFR exon 19 deletions or exon 21 L858R | + carboplatin and pemetrexed | 2nd line, advanced | After failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI) |
| EGFR exon 20 insertion | Monotherapy | 2nd line, advanced | After failure of platinum-based therapy |

## Products

### Rybrevant

- Target: EGFR × MET bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX18
- EU approval: 9 Dec 2021
- Label revised: 16 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/rybrevant-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant

Mechanism (SmPC section 5.1): Binds extracellular domains of EGFR and MET, blocking ligand binding, promoting receptor degradation, and directing immune effector cell destruction via ADCC and trogocytosis.

## Label wording

- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 1st line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 2nd line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 1st line, advanced: “in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 2nd line, advanced: “as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/amivantamab