FDA Approves MRI-Guided Focused Ultrasound Ablation for Bone Metastasis Pain
InSightec Limited's ExAblate MRIgFU targets nerves near metastases for ablation, easing pain symptoms, according to an international, multi-center randomized, placebo (sham treatment)-controlled phase 3 clinical trial that was presented to the FDA as part of the company's premarket approval (PMA) application. Detailed results from the trial will be presented at the ASTRO 2012 annual meeting next week, company officials told Chemotherapy Advisor. The company has reported an “excellent” safety profile and high rates of patient-reported declines in pain associated with bone metastases.
“Pain palliation by ExAblate can dramatically improve the quality of life for cancer patients with bone metastases,” reported Mark Hurwitz, MD, Director of Thermal Oncology at Thomas Jefferson University in Philadelphia, Pennsylvania, who was the lead author of the clinical trial reviewed by the FDA. “Results from the clinical study showed that ExAblate therapy significantly reduces pain caused by bone metastases. Patients also reported lasting improvement in well-being and function, along with a decrease in the need for medication.”
MRI is used to plan and provide continuous in-treatment targeting guidance and to provide real-time, noninvasive temperature measurement, and to monitor treatment outcomes. Focused ultrasound energy noninvasively heats and kills target tissue.
“Pain is the most common and severe symptom of bone metastases, often causing significant physical and emotional discomfort with a large impact on enjoyment of life,” Hurwitz noted.
The FDA previously approved ExAblate for treating uterine fibroids in 2004. ExAblate has also been approved in Europe for treating bone metastases, uterine fibroids, and adenomyosis; the system is in clinical use for bone metastasis pain palliation in 20 hospitals in Europe and Asia, the company reports.
A multicenter postmarketing study involving 70 United States patients with painful bone metastases will be undertaken, and a commercial registry for patients treated with ExAblate will be established next year.