-- Designation of High Unmet Medical Need allows for accelerated review of regulatory submissions in Japan, the second largest medical device market in the world
ST. HELIER, Jersey, Sept. 4, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today 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."
"I am very pleased that the MHLW and PMDA have taken this important action," said Ryo Nishikawa, MD, Ph.D., Vice President of the Japanese Society of Neuro-Oncology, and Professor, Department of Neurosurgery, Saitama International Medical Center, Saitama Medical University. "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."
About the NovoTTF-100A System
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.
The FDA has approved the NovoTTF-100A System for use as a treatment for adult patients (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. The System is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in use of the system. Full prescribing information is available at www.novottftherapy.com or by calling toll free 1-855-281-9301.
Novocure Limited is a private, Jersey Isle company pioneering a novel therapy for solid tumors called NovoTTF Therapy. Novocure's U.S. operations are based in Portsmouth, NH and New York, NY. The company also has offices in Malvern, PA, Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Peter Melnyk, Novocure