Updated on 11 January 2016
Novocure has submitted a premarket approval (PMA) partial amendment application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Optune, a Tumor Treating Fields (TTFields) therapy delivery device, in patients with newly diagnosed glioblastoma.
Novocure is a Jersey Isle oncology company pioneering a therapy for solid tumors called TTFields.
The Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of Optune in patients with recurrent glioblastoma in March 2015.
Optune was approved for the treatment of newly diagnosed glioblastoma by the US FDA on October 5, 2015, based on the successful results of the EF-14 phase 3 trial.
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.