FDA approvesTecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer.- Genentech/Roche

Genentech, announced that the FDA has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained greater than 50% of tumor cells [TC ? 50%] or PD-L1 stained tumor-infiltrating [IC] covering greater than 10% of the tumor area [IC ? 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

This approval is based on an interim analysis from the Phase III IMpower110 study, which showed Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3–4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks.