A new FDA approved device has been shown to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A device, which weighs about six pounds (three kilograms), creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division.
The makers of the device, Novocure, state:
"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective. The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent glioblastoma (GBM) patients and indirectly on their families."
Glioblastoma is the most aggressive and most common form of primary brain tumor in the United States. The disease affects approximately 17,000 Americans each year. The median overall survival time from initial diagnosis is 15 months with optimal therapy, and median survival from the time of tumor recurrence is only three to four months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.
Asaf Danziger, CEO of Novocure continues:
"We move forward from today proud of the efforts and accomplishments of our team, thankful to our investors for their support and guidance, and humbled by the trust of our patients and physicians. Our next task is to make NovoTTF therapy available as a treatment option for all recurrent GBM patients in the U.S. The FDA approval of the NovoTTF device is the culmination of ten years of research, development and clinical trials conducted by an exceptional team of scientists, engineers, and clinicians...we look forward to bringing this device to recurrent GBM patients and their families, and we look forward to developing NovoTTF therapy for a range of additional solid tumor cancers."
FDA approval was based on data from a randomized pivotal trial of 237 patients with glioblastoma tumors that had recurred or progressed despite previous surgical, radiation and chemotherapy treatments. Patients treated with the NovoTTF alone achieved a comparable overall survival time to patients treated with the physician's choice of the best chemotherapy.
NovoTTF treated patients reported better quality of life scores and fewer side effects during the trial compared to patients treated with chemotherapy. Specifically, quality of life using the device was better than that of chemotherapy patients in the following subscale domains: vomiting, nausea, pain, diarrhea, constipation, cognitive functioning and emotional functioning, all of which are hallmarks of patient suffering while receiving chemotherapy. The most commonly reported side effect from NovoTTF treatment was a mild-to-moderate rash beneath the electrodes.
Of the estimated 17,000 primary brain tumors diagnosed in the United States each year, approximately 60% are gliomas. Gliomas comprise a heterogeneous group of neoplasms that differ in location within the central nervous system, in age and sex distribution, in growth potential, in extent of invasiveness, in morphological features, in tendency for progression, and in response to treatments.
Written by Sy Kraft