Novocure (NSDQ:NVCR) said today that the Japanese Ministry of Health, Labor and Welfare has approved its tumor treating fields delivery system, Optune, for adult patients with supra-tentorial glioblastoma following surgery and radiation therapy.
The St. Helier, N.J.-based company is expected to submit an application for public reimbursement of the device in Japan for newly diagnosed GBM.
“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,” CEO Asaf Danziger said in prepared remarks. “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.”
The company’s TTFields are low-intensity, alternating electric fields meant to inhibit cancer cell replication and cause cell death. The Japanese ministry’s approval was supported by Novocure’s phase III EF-14 trial, which evaluated Optune paired with temozolomide versus just temozolomide. The data showed a statistically significant extension of survival in GBM patients using the drug-device combination.
“This approval is a significant moment for newly diagnosed GBM patients in Japan,” president of the Japanese Society of Neuro-Oncology Dr. Ryo Nishikawa said. “Optune provides patients with an additional treatment option, one that has been proven to extend survival.”
“We have been eagerly anticipating this day,” Novocure’s general manager for Japan Shungo Matori added. “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.”