Amivantamab

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

Approved indications of Amivantamab
Biomarker requirement	Regimen	Setting	Conditions

Non-small cell lung cancer4
EGFR exon 20 insertion	+ carboplatin and pemetrexed	1L advanced	None
EGFR exon 19 deletions or exon 21 L858R	+ lazertinib	1L advanced	None
EGFR exon 19 deletions or exon 21 L858R	+ carboplatin and pemetrexed	2L advanced	After failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI)
EGFR exon 20 insertion	Monotherapy	2L advanced	After failure of platinum-based therapy

Full text of section 4.1 (therapeutic indications)

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.  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).  in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations.  as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy. Rybrevant subcutaneous formulation is indicated:

Label history

13 changes to the Rybrevant label since 2022, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.