FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Japan’s MHLW Clears Novocure Second Generation Optune

March 21, 2017

New Jersey–based Novocure has gained approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its second generation Optune, which delivers a low-intensity electrical field to treat cancer.

The device features a tumor treating fields (TTF) generator that is less than half the weight and half the size of the first generation product, weighing less than 2.7 pounds.

In December 2016, the MHLW approved Optune for the treatment of newly diagnosed glioblastoma (GBM).  

Optune is approved in Japan for treatment of adult patients with supra-tentorial GBM and is used following maximal safe surgical resection and radiation therapy. In the U.S., Optune is used as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme. — Cynthia Jessup