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NovoCure wins expanded indications for Optune brain tumor-zapping device

NovoCure said it won expanded indications from the FDA and a new CE Mark indication in the European Union for its brain-tumor treating Optune device. The Optune device uses NovoCure’s “tumor treating fields,” which use low-intensity, intermediate-frequency alternating electric fields that limit cancer cell replication and kill cancer cells, the St. Helier, N.J.-based company said. The FDA granted NovoCure clearance for its Optune in combination with prescribed temozolomide for the treatment of adult patients with newly diagnosed glioblastomas. “Novocure is committed to helping patients with glioblastoma, and we are proud that Optune has been shown to offer patients such a significant improvement in both progression-free and overall survival. Glioblastoma is the most common form of primary brain cancer which, until now, has not seen any significant therapeutic improvements in over a decade. We’re thankful to the many patients, their caregivers and healthcare providers who partnered with us to develop a treatment that has finally led to a significant improvement in the outcomes for patients with glioblastoma,” CEO Asaf Danziger said in a press release. The clinical study that supported the expanded indication reported that patients treated with the device and drug lived an average of 3 months longer than those who only took the drug, the company said. The new indication was reviewed under the FDA’s priority review program which provides...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Oncology Radiosurgery Regulatory/Compliance NovoCure Source Type: news

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