Roche Receives FDA Approval for Tecentriq in PD-L1-High NSCLC Without Chemotherapy

Roche today announced that the FDA has approved Tecentriq (atezolizumab) as first-line monotherapy for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (TC ≥50% or IC ≥10%) with no EGFR or ALK genomic tumor aberrations. In the Phase 3 IMpower110 trial, Tecentriq demonstrated a statistically significant improvement in overall survival compared to chemotherapy in patients with high PD-L1 expression. The median OS was 20.2 months for Tecentriq versus 13.1 months for chemotherapy. This approval provides patients with PD-L1-high NSCLC a chemotherapy-free first-line treatment option.