Japanese Authorities Approve Glioblastoma Device From Novocure

Novocure Ltd., which makes cancer treatment devices, has earned approcal from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Optune, a tumor treating fields (TTFields) delivery device, for the treatment of patients with recurrent glioblastoma. Novocure is headquartered in Jersey Isle.

“We are thankful for the Pharmaceuticals and Medical Devices Agency’s 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 glioblastoma patients rapid access and full reimbursement for Optune.”

CEO Asaf Danziger expressed the company’s belief that Optume could become the new standard of care for glioblastoma.

Glioblastoma is the most common form of primary brain cancer with approximately 10,000 patients diagnosed each year in the United States 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. According to the company, 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 works by creating 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 Japan, Optune is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted. The device has also received marketing approval in the United States, where it is approved and is a CE marked device approved for sale in the European Union, Switzerland, Australia and Israel. In the United States, Optume is approved 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 similarly to its allowance in Japan, is intended as an alternative to standard medical therapy for glioblastoma after other options are exhausted.

“We believe that Optune is an important new treatment option for patients with recurrent glioblastoma,” said Ryo Nishikawa, M.D., Ph.D., 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 glioblastoma.”

“I believe Optune can offer a real benefit to Japanese patients,” said Masao Matsutani, M.D., 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 some cannot tolerate the severe systemic side effects associated with chemotherapy. Optune can give patients renewed hope without diminishing their quality of life.”

Novocure’s U.S. offices are located in Portsmouth, N.H. and New York, N.Y.