The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Novocure's Optune, a Tumor Treating Fields (TTFields) delivery device, for the treatment of patients with recurrent glioblastoma (GBM).

"This approval is an important milestone for Japanese patients who had very few effective and well tolerated treatment options,” said Asaf Danziger, chief executive officer of Novocure. “Approval in Japan reinforces our belief that Optune is a new standard of care for this very difficult to treat disease.”

“We are thankful for the Pharmaceuticals and Medical Devices Agency’s (PMDA) rapid and diligent review of our submission and for the MHLW’s approval of Optune in Japan," said Shungo Matori, general manager Japan and representative director of Novocure K.K. “We will continue to work closely with the MHLW to allow recurrent GBM patients rapid access and full reimbursement for Optune.”

"We believe that Optune is an important new treatment option for patients with recurrent GBM,” said Ryo Nishikawa, president of the Japanese Society of Neuro-Oncology and Professor, Department of Neurosurgery, Saitama International Medical Center, Saitama Medical University. "The clinical data are compelling and we feel that Optune should be considered as a treatment option for all Japanese patients with recurrent GBM.”

“I believe Optune can offer a real benefit to Japanese patients,” said Masao Matsutani, honorary member of the Japanese Society of Neuro-Oncology and Professor Emeritus Saitama Medical University. “Patients with recurrent GBM have very few effective therapeutic options and some cannot tolerate the severe systemic side effects associated with chemotherapy. Optune can give patients renewed hope without diminishing their quality of life.”

Glioblastoma is the most common form of primary brain cancer with approximately 10,000 patients diagnosed each year in the US and approximately 1,600 patients diagnosed each year in Japan. The disease is known as recurrent glioblastoma when the tumor progresses or recurs after initial treatment. Overall survival from the time of recurrence has been reported at 3.5 months without effective treatment.

Optune is a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that Optune slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. Optune 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. Optune has received marketing approval in the United States (US) and Japan and is a CE Marked device approved for sale in the European Union, Switzerland, Australia and Israel.

Optune (the NovoTTF-100A System) is approved in Japan for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.

The US Food and Drug Administration has approved Optune for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma, following histologically or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for glioblastoma after surgical and radiation options have been exhausted. Patients should only use Optune under the supervision of a physician properly trained in use of the device.

Novocure is a private oncology company pioneering a novel therapy for solid tumors called Tumor Treating Fields.