The Japanese Ministry of Health and Welfare (MHLW) has granted high unmet medical need designation to Novocure’s TTF-100A system, indicated to treat recurrent glioblastoma.
The designation requires the Japanese Pharmaceutical and Medical Device Agency (PMDA) to accelerate the regulatory review of the pre-market approval (PMA) application for the system.
In July, the company submitted the PMA application for the NovoTTF-100A system to the PMDA.
NovoCure CEO Asaf Danziger said: “We are pleased that the MHLW granted the high unmet medical need designation to the NovoTTF-100A System for the treatment of recurrent glioblastoma.
“This is an important regulatory milestone for Novocure and we will continue to work closely with the PMDA as we advance the NovoTTF-100A System through the Japanese regulatory process.”
The TTF-100A system is a portable, non-invasive medical device designed for continuous use by patients.
Saitama Medical University professor of Department of Neurosurgery and the Japanese Society of Neuro-Oncology vice president Ryo Nishikawa said: “Patients with recurrent glioblastoma have very limited treatment options.
“We need rapid approval of new therapies, such as the NovoTTF-100A System, with demonstrated effectiveness and safety so that we can offer our patients hope of extended survival and quality living.”
Data from the in-vitro and in vivo studies have demonstrated that the TTF-100A system slows and reverses tumour growth by inhibiting mitosis, the process by which cells divide and replicate.
The system weighs about 6lb and creates a low-intensity, alternating electric field within a tumour that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Compared with active chemotherapies, the NovoTTF-100A system has shown clinical efficacy in patients with recurrent glioblastoma brain tumours.
The system has received marketing approval in the US and is a CE Marked device cleared for sale in the European Union (EU), Switzerland, Australia and Israel.
The CE Marked cleared device is now available for sale in the European Union (EU), Switzerland, Australia and Israel.
The US Food and Drug Administration (FDA) has approved the system for use as a treatment for adult patients aged 22 years of age or older with histologically confirmed GBM, following histologically or radiologically confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy.