GE HealthCare will equip a new Theranostics Center of Excellence in Germany with advanced PET/CT imaging and artificial intelligence technologies.
The agency based its decision on results from the Phase III ALINA trial in which Alecensa improved disease-free survival in ALK-positive NSCLC patients.
Patients with EGFR- and MET-altered NSCLC benefitted from treatment with the drug combo after progressing on Tagrisso alone.
The company said the latest positive safety, tolerability, and efficacy data will underpin discussions with regulators in the US, Europe, and Japan.