NovoTTF-100A, a device for treatment of glioblastoma multiforme from Novocure, a subsidiary of Jersey Isle-based Standen Ltd., received FDA approval following a clinical trial and an agency panel recommendation. The device creates an electric field at the tumor site, preventing cancer cells from dividing and the tumor from growing. The system is indicated for patients following tumor recurrence after receiving chemotherapy.
From the announcement:
NovoTTF-100A is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device has been shown in in vitro studies 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. Novocure currently has U.S. and European marketing approvals for the NovoTTF-100A.
The 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. The rate of progression free survival at six months (PFS6) was 21 percent in the NovoTTF group compared to 15 percent in chemotherapy patients. Also, patients treated with the NovoTTF had a 14 percent tumor response rate (RR) compared to 10 percent in chemotherapy treated patients in the trial, and three complete radiographic responses were observed in the NovoTTF group compared to none in chemotherapy patients. 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.
Press release: FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors
Link: Novocure homepage…
Flashbacks: NovoTTF System for Slowing Progression of GBM May Soon Be Available in U.S.; NovoTTF-100A Validated in More GBM Patients in Phase III Trial; NovoTTF as Effective as Chemotherapy for Recurrent Glioblastoma; NovoTTF-100A for Glioblastoma Multiforme