Novocure announces reimbursement approval for Optune in Japan
Novocure announced that the Japanese Ministry of Health, Labour and Welfare has approved the recommendation by Japan's Central Social Insurance Medical Council to provide reimbursement for Optune for the treatment of newly diagnosed glioblastoma. Optune is a noninvasive, portable device approved in Japan to treat newly diagnosed and recurrent GBM. Optune delivers Tumor Treating Fields to selectively disrupt mitosis in dividing cancer cells. Novocure's phase 3 pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival and overall survival. The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM. Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain quality of life for longer compared to patients treated with temozolomide alone.