FDA accepts priority review application for RCC treatment
The FDA has accepted Bristol-Myers Squibb’s supplemental biologics license application for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously granted breakthrough therapy designation for this application, which is the second indication for which the Opdivo-plus-Yervoy combination has received this designation. The application is based on data from the phase III CheckMate –214 study, which was stopped early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival.
Drug companies to collaborate on bladder cancer treatment
TARIS Biomedical LLC, and Bristol-Myers Squibb have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS), in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor nivolumab (Opdivo). The phase Ib trial will evaluate the combination in patients with muscle-invasive bladder cancer who are scheduled for radical cystectomy. TAR-200 is TARIS Biomedical’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder over 7 days.
Enrollment complete for phase IIb study of localized prostate Ca agent
Sophiris Bio Inc. said it has completed enrollment in its phase IIb study to evaluate the safety and tolerability of topsalysin (PRX302) in treating men with clinically significant localized prostate cancer. Topsalysin is an innovative, first-in-class transmembrane pore-forming protein genetically modified to be activated only in the presence of enzymatically active PSA, which is only found within the prostate. The multicenter, open-label study is evaluating the safety and efficacy of targeted intraprostatic administration of topsalysin for the treatment of histologically proven, clinically significant, localized prostate cancer.