​Novocure announced that the FDA has approved Optune in combination with temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM).

Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields—referred to as Tumor Treating Fields (TTFields)—that inhibit cancer cell replication and cause cancer cell death.

Optune is the first FDA-approved therapy in more than a decade to demonstrate statistically significant extension of overall survival in newly diagnosed GBM. The two-year survival rate among patients treated with Optune in combination with temozolomide was 50% higher than in patients treated with temozolomide alone. No significant additive systemic toxicity was observed in the trial, and patients maintained stable quality-of-life, cognitive function and activities of daily living while using Optune.

“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,” said Asaf Danziger, Novocure’s Chief Executive Officer. “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.”

The FDA approval follows a priority review of the Optune Premarket Approval (PMA) supplement application. The FDA grants priority review status to medical devices that are intended to treat life-threatening diseases and that offer clinically meaningful advantages over existing approved alternatives. Optune was previously approved in April 2011 for the treatment of adult patients with GBM following tumor recurrence after receiving chemotherapy.

GBM is the most common and aggressive form of primary brain cancer. An estimated 12,500 people are diagnosed with GBM or tumors that typically progress to GBM in the United States each year. Median overall survival in newly diagnosed patients is approximately 15 months with existing standard therapies.