Novocure’s Optune (NovoTTF-100A) approved in Japan for the treatment of newly diagnosed glioblastoma.
Novocure announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Optune (NovoTTF-100A) — Novocure’s tumor treating fields (TTFields) delivery system — in the treatment of adult patients with supra-tentorial glioblastoma (GBM) following maximal safe surgical resection and radiation therapy. Novocure will prepare to submit an application for public reimbursement of Optune for newly diagnosed GBM in Japan.
“The Japanese MHLW’s approval of Optune represents an important milestone for Novocure, enabling us to treat more patients who suffer from this aggressive disease,” said Novocure CEO Asaf Danziger. “Optune in combination with temozolomide has been clinically proven to extend survival in patients with newly diagnosed GBM, and we look forward to making Optune available to newly diagnosed GBM patients in Japan.”
Novocure established commercial operations in Japan in March 2015 after the MHLW approved Optune for the treatment of recurrent GBM. Approximately 1,500 patients are diagnosed with GBM in Japan each year.
“This approval is a significant moment for newly diagnosed GBM patients in Japan,” said Ryo Nishikawa, MD, Ph.D., president of the Japanese Society of Neuro-Oncology and professor at Saitama Medical University International Medical Center. “Optune provides patients with an additional treatment option, one that has been proven to extend survival.”
The MHLW’s approval of Optune for the treatment of newly diagnosed GBM was supported by Novocure’s phase 3 pivotal EF-14 trial results, which showed significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone. Optune is the first MHLW-approved therapy in more than a decade to demonstrate statistically and clinically significant extension of survival in newly diagnosed GBM patients.
“We have been eagerly anticipating this day,” said Shungo Matori, Novocure’s general manager Japan and Representative Director of Novocure K.K. “Newly diagnosed GBM patients have experienced an unmet need for better treatment options. We are dedicated to making Optune available to all GBM patients who can benefit from our therapy in Japan.”
Headquartered in Jersey Isle, Novocure has U.S. operations in Portsmouth, NH, Malvern, PA, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Haifa, Israel. www.novocure.com.
(Source: Business Wire)