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.
Rozlytrek : EPAR - Overview (PDF/136.07 KB)
First published: 11/09/2020
Rozlytrek: EPAR - Risk-management-plan summary (PDF/125.04 KB)
First published: 15/05/2023
Last updated: 16/05/2023
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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.
Roche Registration GmbH
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07/07/2023 Rozlytrek - EMEA/H/C/004936 - R/0015
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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.