11 April 2016 - Roche today announced that the U.S. 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.

Atezolizumab was granted Breakthrough Therapy Designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease).

The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study, and the FDA will make a decision on approval by Oct. 19, 2016. A Premarket Application is also under review by the FDA for a companion immunohistochemistry test developed by Roche Tissue Diagnostics.

For more details, go to: http://www.roche.com/media/store/releases/med-cor-2016-04-11.htm