The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Novocure's second generation Optune. Second generation Optune features a Tumor Treating Fields (TTFields) generator that is less than half the weight and half the size of the first generation generator, weighing less than 1.3 kilograms (2.7 pounds). The smaller, lighter TTFields delivery system is now available to glioblastoma (GBM) patients in all of Novocure’s active markets.
“The MHLW’s approval of second generation Optune represents another important milestone for Novocure in Japan as we prepare for a broad commercial launch pending reimbursement approval,” said Shungo Matori, Novocure’s General Manager, Japan and Representative Director of Novocure K.K. “We are dedicated to making Optune available to GBM patients who can benefit from our therapy. This approval enables us to provide Japanese patients with the latest TTFields technology, designed to be make it even easier for patients to incorporate treatment with Optune into their lives.”
Novocure established commercial operations in Japan in March 2015 after the MLHW approved Optune for the treatment of recurrent GBM. In December 2016, the MLHW approved Optune for the treatment of newly diagnosed GBM and Novocure is currently preparing to submit an application for public reimbursement of Optune. Approximately 1,500 people are diagnosed with GBM or tumors that typically progress to GBM in Japan each year.
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.