Uro Pipeline: FDA accepts biologics license application for bladder Ca agent
FDA accepts Biologics License Application for bladder Ca agent
AstraZeneca, along with its research and development branch, MedImmune, has received a Biologics License Application (BLA) from the FDA for the investigational agent durvalumab. The BLA submission is for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after a platinum-based regimen. Durvalumab, a PD-L1 human monoclonal antibody (mAb), was also was granted priority review status with a Prescription Drug User Fee Act date set for the second quarter of 2017. In the phase III DANUBE trial, durvalumab is being tested both as a monotherapy and in combination with tremelimumab (CTLA-4 mAB).
Enrollment for trial of device-based BPH treatment completed
PROCEPT BioRobotics has completed enrollment for a phase III study of its AquaBeam System for the treatment of BPH. The Waterjet Ablation Therapy for Endoscopic Resection (WATER) study enrolled 184 male patients between the ages of 45 and 80 years old who have urinary symptoms resulting from BPH. The study evaluates the efficacy of the AquaBeam System as compared to transurethral resection of the prostate. The system uses surgical robotics along with real-time prostate imaging to deliver the Aquablation therapy. In the procedure, a targeted, heat-free waterjet is used to immediately remove prostate tissue to treat lower urinary tract symptoms caused by BPH. The imaging helps the surgeon to draw a treatment contour that conforms to the shape of the prostate adenoma so that it does not interfere with anatomic markers responsible for continence and ejaculatory function. The study is being performed at 17 sites across four countries.
Trial begins for miniature implantable device for OAB treatment
StimGuard has enrolled its first patient in a clinical trial of a miniature implantable device for the treatment of urgent urinary incontinence due to overactive bladder syndrome. The device uses wireless technology and is placed through a needle-sized introducer at the tibial nerve to activate the afferent micturition pathway. StimGuard’s “PROTECT” Study is a randomized, controlled study that compares the efficacy of the device with a recurring treatment. Using ultrasound guidance, the device is implanted at the tibial nerve, and an externally worn transmitter provides energy and to the device at night. The trial includes approximately 242 patients and will commence this winter.