🇪🇺 LAZERTINIB in European Union

EMA authorised LAZERTINIB on 20 January 2025

Marketing authorisation

EMA — authorised 20 January 2025

  • Application: EMEA/H/C/006074
  • Marketing authorisation holder: Janssen Cilag International NV
  • Local brand name: Lazcluze
  • Indication: Lazcluze in combination with amivantamab is indicated 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.
  • Status: approved

The European Medicines Agency (EMA) has approved Lazcluze (lazertinib) in combination with amivantamab for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring EGFR exon 19 deletions or exon 21 L858R substitution mutations. This approval was granted on 20 January 2025. Lazcluze is manufactured by Janssen Cilag International NV.

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LAZERTINIB in other countries

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

Frequently asked questions

Is LAZERTINIB approved in European Union?

Yes. EMA authorised it on 20 January 2025.

Who is the marketing authorisation holder for LAZERTINIB in European Union?

Janssen Cilag International NV holds the EU marketing authorisation.