Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has conditionally authorized entrectinib for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

This is written in the approval document as:

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.

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::ROS1	Non-Small Cell Lung Cancer	Entrectinib