Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::ROS1 status confers therapeutic sensitivity to Entrectinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2020-07-31	European Medicines Agency	Indication received approval from the European Commission.