Genentech, announced that the U.S. Food and Drug Administration (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 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). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.
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 BLA submission for atezolizumab is based on results of the IMvigor 210 Phase II study, and the FDA will make a decision on approval by Sept. 12, 2016. Atezolizumab is also being studied in a number of other cancers.
