FDA Accepts BLA and Grants Priority Review for Roche’s ImmunotherapyBy
The US Food and Drug Administration (FDA) has accepted Roche’s biologics license application (BLA) and granted priority review for atezolizumab for treating locally advanced or metastatic urothelial carcinoma (mUC) in patients 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 or after surgery. Urothelial carcinoma accounts for 90% of all bladder cancers.
A priority review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Atezolizumab was granted breakthrough therapy designation by the FDA in May 2014 for the treatment of people whose metastatic bladder cancer expresses the protein PD-L1 (programmed death ligand-1). 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 September 12, 2016. Atezolizumab is also being studied in a number of other cancers.
Atezolizumab is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.