The panel felt the interim data of 100 patients in a 200-patient trial was insufficient to recommend approval, and they advised the company to continue their ongoing study. The experts voted that the risk of the treatment was too high for the limited efficacy demonstrated, that there is not reasonable assurance that the system is effective for this population, and that the benefits do not outweigh the risks based on the evidence presented. Sonablate did receive some positive votes for safety and efficacy, but not enough to meet the level of evidence needed to recommend approval in the United States.
Comments from the committee indicated that they would like to see a larger volume of data on more patients over a longer period of time. The panel also raised questions about which patient population will most benefit from focused ultrasound treatment of prostate cancer. They offered strong guidance regarding the type of patient for whom they believe the technology would be best suited, namely patients with a Gleason score greater than 6. In this category of patients, the panel felt that the follow-up period might be shortened, the hurdle rate for success might be lowered, and the level of morbidity that would be acceptable might be raised.
"SonaCare is already in the process of assessing a subset of subjects that meet the Panel's recommendations...we look forward to working with FDA to explore this and other paths that may allow us to realize our goal of achieving approval for the technology and making it available to men living with radio-recurrent prostate cancer."-Mark Carol, SonaCare's Chief Development Officer
Work remains to find a place for focused ultrasound in treating US patients with prostate cancer. This marks the second focused ultrasound prostate system to come under review in the past few months. EDAP’s system for low risk prostate cancer was rejected at a hearing in July.
Read more about the Sonacare panel - http://www.medscape.com/viewarticle/832705?src=rss