Roche’s Tecentriq Gets FDA Priority Review for Advanced Non-Small Cell Lung Cancer

The FDA granted Roche’s Tecentriq priority review (atezolizumab) as a first-line monotherapy for patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type).

The supplemental BLA is based on results from a phase 3 clinical trial, which showed that Tecentriq monotherapy improved overall survival compared with chemotherapy in patients with high PD-L1 expression (TC3/IC3-WT).

Tecentriq is currently approved for treating various forms of non-small cell and small cell lung cancer, PD-L1-positive metastatic triple-negative breast cancer, and certain types of metastatic urothelial cancer.