EMA indication #2: Entrectinib monotherapy is indicated for treatment of adult patients with ROS1-positive advanced NSCLC not previously treated with ROS1 inhibitors [43].Clinical evidence approval EMA indication #2: Several studies, including the phase I ALKA study (NCT02097810), phase I STARTRK-1 study (NCT02097810), and phase II STRATRK-2 study (NCT02568267), all of them in adult patients. The gene discussed is ROS1; the disease is non-small cell lung carcinoma.