Novocure, a commercial stage oncology company, announced that the Japanese Ministry of Health and Welfare (MHLW) has granted High Unmet Medical Need designation to the NovoTTF-100A System.
This 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 for the treatment of recurrent glioblastoma. Novocure submitted the NovoTTF-100 A PMA application to the PMDA in July 2014.
"We are pleased that the MHLW granted the High Unmet Medical Need designation to the NovoTTF-100A System for the treatment of recurrent glioblastoma," commented Asaf Danziger, CEO of Novocure. "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."
NovoTTF-100A System is a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that the NovoTTF-100A System slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate.
The NovoTTF-100A System weighs about six pounds (three kilograms) and creates a low intensity, alternating electric field within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
In patients with recurrent glioblastoma brain tumors, the system has shown clinical efficacy comparable to that of active chemotherapies with better quality of life and without many of the side effects of chemotherapy. The NovoTTF-100A System has received marketing approval in the United States (U.S.) and is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.