FDA Accepts Roche’s BLA for Its Cancer Immunotherapy Atezolizumab
The US Food and Drug Administration (FDA) has accepted Roche’s biologics license application (BLA) and granted priority review for its immunotherapy, atezolizumab, 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). Breakthrough therapy designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The FDA will make a decision on approval by October 19, 2016. A premarket application is also under review by the FDA for a companion immunohistochemistry test developed by Roche Tissue Diagnostics.
This is the second BLA acceptance and priority review for atezolizumab. In March 2016, Roche announced that the FDA had accepted the company's BLA and granted priority review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Atezolizumab is also being studied in a number of other cancers.