Priority review designation at FDA for atezolizumab (MPDL 3280A) for treatment of locally-advanced or metastatic non-small cell lung cancer- Genentech/Roche

Genentech announced that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.

Comment: The FDA will make a decision in whether to approve atezolizumab in NSCLC on 19 October 2016.

Comment: Genetech is competing with AstraZeneca with its durvalumab to be the third of a new class of cancer immunotherapies to gain US approval, behind the leaders Merck and Bristol-Myers Squibb and their products Keytruda (pembrolizumab) and Opdivo (nivolumab) respectively.