FDA Approves Improved Optune System for Glioblastoma Multiforme

A lighter and more convenient version of the tumor-treating field device Optune for patients with glioblastoma multiforme (GBM) received FDA approval July 13 for the treatment of this aggressive type of brain tumor.

Optune is a portable, noninvasive, battery-operated device that attaches to the patient's head to deliver tumor-treating fields to the brain. The new version of the device, which is carried by the patient throughout their daily activities, weighs just 2.7 pounds and is easier to transport. The previous version weighed 6 pounds. Patients using the first-generation of the device will be given the opportunity to switch to the newly approved version within the next few weeks.

The first-generation of Optune was most recently approved in 2015 for use in combination with adjuvant Temodar (temozolomide) as a treatment for patients with newly diagnosed GBM following surgery, chemotherapy, and radiation therapy. Optune was initially approved in 2011 for the treatment of recurrent GBM after other surgical and radiation options are exhausted.

“We are happy to receive FDA approval of our second generation Optune system,” Asaf Danziger, chief executive officer at Novocure, the company manufacturing the device, said in a statement. “We believe the improvements incorporated into the second-generation Optune system will make a big difference to the patients and families who face this devastating disease every day. We will continue to work to improve our technology and patient experience.”

The lighter, second-generation Optune device has been used in Germany since October 2015, without issues. The design changes made to the system were meant to improve patient experience and power source management, via displays and alerts when batteries needed to be changed. Additionally, batteries can be changed in the new device without stopping or interfering with treatment.

“The second-generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives," said Mike Ambrogi, Novocure’s Chief Operating Officer. "We have received positive feedback from our second-generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States.”

In findings from the phase III EF-14 study that led to FDA approval in combination with temozolomide, the Optune combination improved overall survival (OS), when compared with the chemotherapy agent alone. In a full analysis of 695 patients enrolled in the phase III study, the median OS was 19.4 months compared with 16.6 months with temozolomide alone. Additionally, progression-free survival (PFS) was improved by approximately 3 months, according to the FDA.

The full study included 700 patients. With longer follow-up than was submitted to the FDA, the 24-month OS rate with Optune in combination with temozolomide was 48% compared with 32% with monotherapy, which was statistically significant (P = .0058). The median PFS was 7.2 versus 4.0 months with the combination and single-agent, respectively, representing a 38% reduction in the risk of progression or death.

The median OS was 20.5 months with Optune compared with 15.6 months for temozolomide, which was a 34% reduction in the risk of death.

"Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available," William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement when the device was approved. "While the treatment is not a cure, it can increase survival by several months."

Adverse events (AEs) were similar between the arms and were primarily associated with temozolomide. The most common AEs related to Optune were skin irritation, which occurred in 45% of patients utilizing the device. As a precaution, the FDA advised against using the device in patients with an active implanted medical device, a skull defect, or a known sensitivity to conductive hydrogels.

Clinical trials continue to assess Optune in various combinations for patients with brain cancer, including a phase II study exploring the treatment in combination with bevacizumab and temozolomide for unresectable GBM. Optune is also being explored in earlier settings in combination with bevacizumab and hypofractionated stereotactic irradiation in bevacizumab-naive patients with recurrent GBM.