Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has conditionally authorized entrectinib for the treatment of adult and pediatric patients 12 years of age and older with solid tumors expressing a neuotrophic 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, and who have no satisfactory treatment options.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::NTRK1	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Entrectinib