Tecentriq + Avastin filed with FDA for NSCLC and given priority review .- Genentech.

Genentech announced that the FDA has accepted the company�s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by September 5, 2018. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

This sBLA is based on results from the Phase III IMpower150 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with advanced non-squamous NSCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.

Comment: Tecentriq is currently approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.