Uro Pipeline: FDA grants priority review to advanced bladder Ca agent
FDA grants priority review to advanced bladder cancer agent
The FDA has accepted Genentech’s Biologics License Application (BLA) and granted priority review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma 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). 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, according to Genentech, which is a member of the Roche group.
First patients enrolled in U.S. IDE trial of BPH treatment
The first patients have been enrolled in the MedLift U.S. investigational device exemption (IDE) trial of the UroLift System. The MedLift IDE trial will be conducted across eight U.S. sites and is designed to demonstrate safety and effectiveness of the UroLift System for the treatment of patients with BPH who have an obstructive median lobe, which is currently contraindicated in the United States. Obstructive median lobes are present in approximately 5% to 10% of BPH patients who would otherwise be eligible for treatment with the UroLift System, according to manufacturer NeoTract, Inc.