Second Treatment Indication on Heels of Multi-Use Clearance for Axxent® System Strengthens the Creation of a New Platform in Radiation Therapy
SUNNYVALE, CA – Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for applicators to be used with the Axxent® Electronic Brachytherapy System for the treatment of endometrial cancer. Previously cleared for accelerated treatment of early stage breast cancer, the Axxent System, a proprietary technology platform designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings, also recently received expanded FDA Clearance for use in the treatment of other cancers or conditions where radiation therapy is indicated.
Endometrial cancer, the most prevalent gynecologic cancer in the United States, is also the fourth most common invasive cancer and represents six percent of all cancer in women. It is a disease where malignant cells form in the tissues of the lining of the uterus, or endometrium. According to the National Cancer Institute, more than 40,000 cases will be diagnosed in 2008 and will result in nearly 7,500 deaths.
While treatment options vary, endometrial cancer is generally treated with surgery, frequently a hysterectomy to remove the uterus, and radiation therapy. Shown to reduce local recurrence, radiation therapy also improves survival in some cases, according to a retrospective study involving more than 21,000 patients published in the Journal of the American Medical Association. The use of brachytherapy for endometrial cancer is well established among radiation oncologists and the trend has been increasing as clinical experience shows benefits. Nearly two-thirds of cases, approximately 25,000, are eligible for treatment with internal brachytherapy exclusively or in combination with external beam therapy. The American Brachytherapy Society (ABS) has endorsed the recommendations made by the National Comprehensive Cancer Network for the use of brachytherapy in the treatment of endometrial cancer and has issued specific guidelines for technique as well as the application of brachytherapy.
“Accelerated treatment of breast cancer using Electronic Brachytherapy has been very well received by our patients and we are very excited to be able to offer the benefits of this non-radioactive treatment for endometrial cancer,” said Adam Dickler, MD, radiation oncologist at Little Company of Mary Hospital in Evergreen Park, Illinois. “The ability to deliver electronic X-ray based therapy directly to the tissue at risk, spares surrounding organs and gives us the ability to provide that therapy in a broader spectrum of clinical settings, making it safer and more accessible.”