Novocure Announces the Submission of a Pre-Marketing Approval Application in Japan for the NovoTTF™-100A System to Treat Recurrent Glioblastoma
Japanese Society of Neuro-Oncology calls for rapid approval by the Japanese Ministry of Health and Welfare (MHLW)
Marketing approval would provide Novocure with the ability to pursue a direct distribution model in Japan, the second largest medical device market in the world
ST. HELIER, Jersey, Aug. 21, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today that it has submitted the registration dossier for Pre-Market Approval (PMA) of the NovoTTF-100A System to treat recurrent glioblastoma to the Japanese Pharmaceutical and Medical Device Agency (PMDA). Glioblastoma is the most common and deadly form of primary brain cancer. The disease is known as recurrent glioblastoma when the tumor progresses or recurs after initial treatment.
"Over the last year, we have been working very closely with the MHLW and PMDA officials in preparation for our filing," said Asaf Danziger, Chief Executive Officer of Novocure. "Given the high unmet medical need for new therapies in recurrent glioblastoma, we will continue to work closely with the regulatory authorities to bring NovoTTF Therapy to Japanese patients as quickly as possible. We will also continue to support compassionate use requests from certified physicians for patients with recurrent glioblastoma while we await regulatory approval."
"We believe that NovoTTF Therapy is an important new treatment option for patients with recurrent glioblastoma," 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. "We respectfully ask that the MHLW look favorably at the filing and accelerate approval for our patients in need of new options."
"I believe that NovoTTF Therapy can offer a real benefit to Japanese patients given its demonstrated efficacy and unique safety and quality-of-life profile," said Masao Matsutani, MD, Ph.D, Honorary Member of the Japanese Society of Neuro-Oncology, and Professor Emeritus, Saitama Medical University. "Patients with recurrent glioblastoma have very few effective therapeutic options and many cannot tolerate the severe systemic side effects associated with traditional chemotherapies."
About the NovoTTF-100A System
The 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 U.S. Food and Drug Administration (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 oncology company pioneering a novel therapy for solid tumors called NovoTTF Therapy. Novocure U.S. operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Peter Melnyk, Novocure