🇪🇺 Rozlytrek in European Union

EMA authorised Rozlytrek on 31 July 2020

Marketing authorisations

Application: EMEA/H/C/004936
Marketing authorisation holder: Roche Registration GmbH
Local brand name: Rozlytrek
Indication: Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhi
Pathway: conditional, PRIME
Status: approved

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

Is Rozlytrek approved in European Union?

Yes. EMA authorised it on 31 July 2020; EMA has authorised it.

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

Roche Registration GmbH holds the EU marketing authorisation.