NCCN Issues Updated Recommendation for Optune as a Treatment for GBM

The National Comprehensive Cancer Network (NCCN) has issued an updated recommendation for Optune for use in combination with temozolomide (Temodar) as standard treatment for patients with newly diagnosed glioblastoma multiforme (GBM).

Since 2015, Optune had a category 2B recommendation (stating that there is an NCCN consensus that the intervention is appropriate) for recurrent GBM. The NCCN now designates Optune a category 2A recommendation (stating that there is a uniform NCCN consensus that the intervention is appropriate) for newly diagnosed GBM patients with good performance status.

Novocure, the manufacturer of the device formerly known as NovoTTF-100A System, made the announcement July 26.

“The NCCN guidelines aim to assist patients, their families and their medical teams in making informed treatment-related decisions with the goal of optimal cancer care,” said Eilon Kirson, MD, PhD, chief science officer at Novocure, in a statement. “We believe the inclusion of Optune as a standard treatment option for newly diagnosed GBM serves as further validation of this noninvasive cancer therapy that has been shown to extend survival in newly diagnosed GBM.”

Optune is a portable device that is powered by a battery and attaches to the patient's head to deliver tumor-treating fields to the brain. The treatment appears to both slow and reverse tumor growth by inhibiting mitosis during metaphase, anaphase, and telophase.

Optune was initially approved by the FDA in 2011 for the treatment of recurrent GBM after other surgical and radiation options were exhausted.

The combination of Optune and temozolomide was then approved for patients with newly-diagnosed GBM in October 2015 based on results from the phase 3 EF-14 study. In that trial of 695 patients, median overall survival (OS) was 19.4 months among those treated with the combination compared with 16.6 months among those receiving temozolomide alone. After a 24-month follow-up, the OS rate was 48% with the combination and 32% with temozolomide alone.

Adverse events were similar between the combination and temozolomide monotherapy arms and were related to temozolomide primarily. Skin irritation was the most common event related to Optune and occurred in 45% of patients.

In July 2016, a smaller and lighter version of the device was approved by the FDA. The new device weighs 2.7 pounds, considerably lighter than the original version (which was 6 pounds).

Physicians typically look to NCCN guidelines to determine the best course of treatment, said Pritesh Shah, a senior vice president at Novocure, in a statement. The new NCCN recommendation will likely help Novocure educate more community oncologists.