FDA approves atezolizumab for first | 合法醫療器材資訊網

FDAapprovesatezolizumabforfirst-linetreatmentofmetastaticNSCLCwithhigh...OnMay18,2020,theFoodandDrugAdministrationapprovedatezolizumab ...

On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations.

Today, the FDA also approved the VENTANA PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with atezolizumab.

Efficacy was evaluated in IMpower110 (NCT02409342), a multicenter, international, randomized, open-label trial in patients with stage IV NSCLC whose tumors express PD-L1 (TC ≥ 1% or IC ≥ 1%), who had received no prior chemotherapy for metastatic disease. Pat...