BioCentury
ARTICLE | Clinical News

Atezolizumab regulatory update

April 18, 2016 7:00 AM UTC

FDA accepted and granted Priority Review to a BLA from Roche’s Genentech unit for atezolizumab to treat PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed on or after platinum-containing chemotherapy. The PDUFA date is Oct. 19. A PMA for Roche’s companion immunohistochemistry test is also under FDA review. ...