Updated on 25 October 2012
FDA approves radiation therapy for bone pain
Singapore: InSightec received US FDA approval for ExAblate MRI-guided focused ultrasound for use as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain.
This is the second FDA approval for ExAblate, which has been used widely since it was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids. Bone metastases occur when cancer cells break away from their primary site and spread to other parts of the body.
"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," says Dr Mark Hurwitz, principal investigator of the international, multi-center, randomized study that formed the basis of InSightec's pre-market approval (PMA) application with the FDA.
"Pain palliation by ExAblate can dramatically improve the quality of life for cancer patients with bone metastases. Results from the clinical study showed that ExAblate therapy significantly reduces pain caused by bone metastases. Patients also reported lasting improvement in wellbeing and function, along with a decrease in the need for medication."
Dr Hurwitz, who is currently director of thermal oncology and vice chair of the radiation oncology department at Thomas Jefferson University in Philadelphia, led the study during his previous tenure as director of regional program development for the department of radiation oncology at Brigham and Women's Hospital.