Uro Pipeline: FDA accepts two supplemental applications for mUC agent
FDA accepts two supplemental applications for mUC agent
The FDA has accepted for review two supplemental Biologics License Applications for Merck’s pembrolizumab (Keytruda). The drug is an anti-PD-1 therapy for patients with locally advanced or metastatic urothelial cancer (mUC). The application Merck submitted for first-line use was accepted and granted Priority Review for mUC patients who are ineligible to receive cisplatin-containing therapy. The Prescription Drug User Fee Act target action date for both applications is June 14, 2017. Both applications are based on results from a phase II and phase III study and are seeking approval for pembrolizumab monotherapy at an intravenously administered dose of 200 mg every 3 weeks.
GnRH antagonist for prostate cancer moves into phase III study
Myovant Sciences has begun a phase III clinical trial to evaluate the safety and efficacy of relugolix in the treatment of advanced prostate cancer. The drug is a once-daily, oral gonadotropin-releasing hormone receptor antagonist that reduces testosterone levels by inhibiting pituitary release of luteinizing hormone and follicle stimulating hormone. The study is a randomized, parallel-group international clinical trial that has enrolled approximately 1,125 patients. Patients will be randomized 2:1 to receive either relugolix, 120 mg once daily, or leuprolide acetate 3-month depot injection, respectively. The primary efficacy outcome is for relugolix to reach and maintain testosterone suppression levels equal to castrate levels (£50 ng/dL) for 48 weeks.