This medicine is authorised for use in the European Union.


Rozlytrek is a cancer medicine. It can be used for treating patients from 12 years of age with solid tumours (cancer growths) that have a genetic abnormality called NTRK gene fusion. Rozlytrek is for use in patients with tumours that have spread nearby or to other parts of the body (metastatic cancer) or when removing the tumour by surgery could cause severe harm. It should be used only if the patient has not been treated previously with a medicine that works in the same way as Rozlytrek and other treatments are not suitable.

Rozlytrek can also be used for treating adults with advanced non-small-cell lung cancer that has a genetic abnormality called ROS1 gene fusion. It should be used only if the patient has not been treated previously with a medicine that blocks ROS1.

Rozlytrek contains the active substance entrectinib.

This EPAR was last updated on 18/07/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Cancer
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Roche Registration GmbH 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen

Product information

07/07/2023 Rozlytrek - EMEA/H/C/004936 - R/0015

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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 inhibitors.

Assessment history

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