Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	v::NTRK1	Any solid tumor	Entrectinib
EMA (1)	v::NTRK2	Any solid tumor	Entrectinib
EMA (1)	v::NTRK3	Any solid tumor	Entrectinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2024-06-27	European Medicines Agency	Indication received approval from the European Commission.