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.