NCCN Strengthens Recommendation for Optune in Glioblastoma Multiforme

The National Comprehensive Cancer Network (NCCN) has issued an updated recommendation for Optune for use in combination with Temodar (temozolomide) 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 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,” Eilon Kirson, the chief science officer at Novocure, said 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 Temodar 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 Temodar alone. After a 24-month follow-up, the OS rate was 48 percent with the combination and 32 percent with Temodar alone.

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

“Increased physician awareness will help us to reach patients earlier in the course of this aggressive disease, which should translate to better outcomes.”