The treatment is for patients with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or after platinum-based chemotherapy in the metastatic setting, or whose disease worsened within one year of receiving platinum-based chemotherapy prior to or after surgery.
Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to bind with a protein dubbed programmed death ligand-1 (PD-L1).
It binds to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing its interactions with PD-1 and B7.1 receptors.
The priority review designation was based on results of the IMvigor 210 Phase II study, which evaluated the safety and efficacy of atezolizumab in people with locally advanced or mUC, regardless of PD-L1 expression.
The study demonstrated that the medicine shrank tumors in a type of advanced bladder cancer, and most of the patients continued to respond to treatment after nearly a year of follow up.
The FDA will decide on approval by 12 September 2016. Atezolizumab is also being studied in several other cancers.
Roche chief medical officer and head of global product development Sandra Horning said: "The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible."
The FDA granted breakthrough therapy designation to atezolizumab in May 2014 to treat people whose metastatic bladder cancer expresses the protein PD-L1.
Last month, the FDA approved Roche’s Gazyva (obinutuzumab) to treat certain people with previously treated follicular lymphoma.
Image: Roche Basel with the buildings 68 and 48. Photo: courtesy of F. Hoffmann-La Roche Ltd.