Rozlytrek (entrectinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Roche Registration GmbH. Rozlytrek (entrectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf. Revised July 2023. Accessed March 22, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than one month with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have not received a prior NTRK inhibitor, (iii) who have no satisfactory treatment options.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	v::ROS1	Non-Small Cell Lung Cancer	Entrectinib
EMA (1)	v::NTRK1	Any solid tumor	Entrectinib
EMA (1)	v::NTRK2	Any solid tumor	Entrectinib
EMA (1)	v::NTRK3	Any solid tumor	Entrectinib