🇪🇺 MRTX849 in European Union

EMA authorised MRTX849 on 5 January 2024

Marketing authorisation

EMA — authorised 5 January 2024

  • Application: EMEA/H/C/006013
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Krazati
  • Indication: Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.
  • Pathway: conditional
  • Status: approved

On 5 January 2024, the European Medicines Agency (EMA) granted a conditional marketing authorisation for Krazati (MRTX849), a treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation. This authorisation was granted under the conditional approval pathway. Krazati is indicated for patients with disease progression after at least one prior systemic therapy.

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MRTX849 in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is MRTX849 approved in European Union?

Yes. EMA authorised it on 5 January 2024.

Who is the marketing authorisation holder for MRTX849 in European Union?

Bristol-Myers Squibb Pharma EEIG holds the EU marketing authorisation.