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% in the NovoTTF group compared to 15% in chemotherapy patients.
The portable, wearable device delivers an anti-mitotic, anti-cancer therapy as patients maintain their normal daily activities.
The NovoTTF-100A device 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 CEO Asaf Danziger said their next task is to make NovoTTF therapy available as a treatment option for all recurrent GBM patients in the US.
