FDA committee votes in favor of nocturia treatment approval
The FDA Bone, Reproductive and Urologic Drugs Advisory Committee has voted 14-4 to approve the benefit-risk profile for the new drug application (NDA) of desmopressin nasal spray (SER120), submitted by Allergan plc and Serenity Pharmaceuticals, LLC. The nasal spray is an investigational drug developed for the treatment of nocturia. According to the committee, which voted 17-1 in favor, there is substantial evidence that at least one of the SER120 doses is effective. The FDA is expected to address the desmopressin nasal spray NDA in the fourth quarter of 2016.
Phase III trial of bladder Ca agent stopped after meeting endpoint
Merck has ended a phase III trial investigating the use of pembrolizumab (Keytruda) after meeting its primary endpoint of overall survival. Pembrolizumab, an anti-PD-1 therapy for patients with advanced urothelial cancer, was superior in comparison to investigator choice chemotherapy. An independent Data Monitoring Committee recommended that the trial be stopped early after a pre-specified interim analysis. Pembrolizumab is being tested in more than 360 clinical trials against more than 30 tumor types. The treatment is administered intravenously over 30 minutes every 3 weeks.
FDA approves IDE to expand study on prostate biopsy system
The FDA has approved an application for an Investigational Device Exemption submitted by Prescision Biopsy. The approval allows the company to expand its clinical trial for the ClariCore Biopsy System by allowing more prostate cancer patients to enroll in the transrectal ultrasound (TRUS) and MR/fusion arms of its study. The ClariCore system is designed to provide real-time classification of prostate tissue during biopsy procedures. The trial, which is taking place across the U.S., is expected to include 200 patients in its three arms.