Rybrevant - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

amivantamab

Opinion

On 14 November 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Rybrevant. The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.

The CHMP adopted a new indication as follows:

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.

For information, the full indications for Rybrevant will be as follows:¹

Rybrveant 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 non small cell lung cancers (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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹ New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Rybrevant (II-13)

AdoptedReference Number: EMA/CHMP/525856/2024

Key facts

• Name of medicine:
  Rybrevant
• EMA product number:
  EMEA/H/C/005454
• Active substance:
  amivantamab
• International non-proprietary name (INN) or common name:
  amivantamab
• Therapeutic area (MeSH):
  Carcinoma, Non-Small-Cell Lung
• Anatomical therapeutical chemical (ATC) code:
  L01FX18
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Janssen-Cilag International N.V.
• Date of opinion:
  14/11/2024
• Status:
  Positive