Novocure announced that the NovoTTF-100A System has been approved by the FDA for the treatment of adult patients with glioblastoma multiforme brain tumors, following tumor recurrence after receiving chemotherapy. This approval was based on results 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-100A alone achieved a comparable overall survival time to patients treated with the physician’s choice of the best chemotherapy. The rate of progression free survival at six months was 21% in the NovoTTF-100A group compared with 15% in chemotherapy patients. Also, patients treated with the NovoTTF-100A had a 14% tumor response rate compared with 10% in chemotherapy treated patients in the trial, and three complete radiographic responses were observed in the NovoTTF-100A group compared with none in chemotherapy patients.
NovoTTF-100A treated patients reported better quality of life scores and fewer side effects during the trial compared with 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.
The NovoTTF-100A is a portable, non-invasive, wearable device which weighs about six pounds (three kilograms). It exerts its anti-cancer effects by creating 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.
For more information visit www.novocure.com.