Japan clears Novocure’s 2nd gen Optune device

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Novocure (NSDQ:NVCR) said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its 2nd-gen Optune device.

The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit cancer cell replication and cause cancer cell death, the St. Helier, N.J.-based company said.

The next-generation device is smaller, lighter and features a tumor treating field generator that is less than half the weight and size of the 1st-generation Optune system, NovoCure said.

“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. 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 Japan GM Shungo Matori said in a press release.

Last month, Novocure said it enrolled the 1st patient in the phase 3 pivotal Lunar trial of its Tumor Treating Field technology for treating patients with advanced non-small cell lung cancer who have failed platinum-based therapy.

The prospective, randomized 512-patient trial from the company aims to test the safety and efficacy of its TTFields technology in combination with standard of care treatments of immune checkpoint inhibitors or docetaxel.

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