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