Posted by Michael Wonder on 18 May 2020
FDA approves Genentech’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer
18 May 2020 - Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall.
Genentech today announced that the U.S. FDA has approved Tecentriq (atezolizumab) as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.
This approval is based on an interim analysis from the Phase III IMpower110 study, which showed Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy (median overall survival=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).
