🇪🇺 Amivantamab IV in European Union

EMA authorised Amivantamab IV on 9 December 2021

Marketing authorisation

Application: EMEA/H/C/005454
Marketing authorisation holder: Janssen-Cilag International N.V.
Local brand name: Rybrevant
Indication: 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 wi
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Amivantamab IV approved in European Union?

Yes. EMA authorised it on 9 December 2021.

Who is the marketing authorisation holder for Amivantamab IV in European Union?

Janssen-Cilag International N.V. holds the EU marketing authorisation.