Atezolizumab has received accelerated FDA approval for treating advanced bladder cancer that is progressing despite platinum-based chemotherapy.
The drug, which will be marketed under the name Tecentriq, is indicated for patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-based chemotherapy or whose disease has worsened within 12 months of receiving this chemotherapy before or after surgery.
According to a press release issued by the drug’s manufacturer, Genentech, atezolizumab is a monoclonal antibody that binds with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells (ICs), thereby blocking interaction with both PD-1 and B7.1 receptors. By inhibiting PD-L1, the drug may enable T cell activation.
The approval is based on the phase 2 IMvigor 210 study, an open-label, multicenter trial that enrolled 310 patients with the aforementioned indications. The primary endpoint was objective response rate (ORR). The median follow-up time was 14.4 months.
The overall ORR was 14.8%; it was 26% in patients with PD-L1 expression of 5% or greater in tumor-infiltrating immune cells (ICs) and 9.5% in those with PD-L1 expression of less than 5% in ICs.
FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit, the press release explained. The indication for atezolizumab received accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.