🇪🇺 Gavreto in European Union

EMA authorised Gavreto on 18 November 2021

Marketing authorisations

EMA — authorised 18 November 2021

  • Marketing authorisation holder: ROCHE REGISTRATION GMBH
  • Status: approved

EMA — authorised 18 November 2021

  • Application: EMEA/H/C/005413
  • Marketing authorisation holder: Blueprint Medicines (Netherlands) B.V.
  • Local brand name: Gavreto
  • Indication: Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
  • Pathway: conditional
  • Status: withdrawn

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Gavreto 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 Gavreto approved in European Union?

Yes. EMA authorised it on 18 November 2021; EMA authorised it on 18 November 2021.

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

ROCHE REGISTRATION GMBH holds the EU marketing authorisation.