Priority Review for Roche's Tecentriq in first-line NSCLC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted and granted Priority Review to an sBLA for Tecentriq atezolizumab in combination with Avastin bevacizumab, paclitaxel and carboplatin as first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The PDUFA date is Sept. 5.

The submission is based on the Phase III IMpower150 study, which tested the Tecentriq combination in patients with metastatic non-squamous NSCLC. The combo showed a survival benefit over Avastin and chemotherapy alone (see BioCentury, March 30)...