The US Food and Drug Administration approved Optune Pax for use concomitantly with gemcitabine and nab-paclitaxel in adult patients with locally advanced pancreatic cancer.
The approval was supported by findings from the phase 3 PANOVA-3 randomized controlled trial, an international, prospective, open-label study that enrolled 571 patients and evaluated the device in the first-line setting. Patients were randomized 1:1 to receive gemcitabine and nab-paclitaxel with or without Optune Pax and were followed for a minimum of 18 months.
The device was approved through the premarket approval pathway, the FDA’s most stringent review process for medical devices, and is described by the agency as a first-of-its-kind, noninvasive therapy for this indication. The decision aligns with the FDA’s Home as a Health Care Hub Initiative, which supports technologies designed for outpatient and home-based care. It represents the first new FDA–approved treatment for locally advanced pancreatic cancer in nearly 30 years. According to the National Cancer Institute, pancreatic cancer accounts for approximately 67,000 new cases and more than 50,000 deaths annually in the US.
In the intent-to-treat population, median overall survival was 16 months in the Optune Pax plus chemotherapy group compared with 14 months in the chemotherapy-alone group. In the modified per protocol population, median overall survival was 18 months with Optune Pax vs 15 months with chemotherapy alone. One-year survival rates were 68% in the Optune Pax group vs 60% in the control group in the intent-to-treat analysis and 75% vs 66%, respectively, in the modified per-protocol population.
Treatment with Optune Pax also prolonged time to pain progression. Median time to pain progression was 15 months in the combination group compared with 9 months in the chemotherapy-alone group, a 6-month extension. Quality-of-life assessments using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 with the pancreatic cancer-specific PAN26 module demonstrated longer deterioration-free survival in global health status, pain, pancreatic pain, and digestive symptoms among patients who received Optune Pax. No significant differences were observed between groups in progression-free survival, local progression-free survival, objective response rate, puncture-free survival, or tumor resectability.
Optune Pax is a wearable, portable medical device that delivers Tumor Treating Fields, alternating electric fields that disrupt processes critical for cancer cell division and survival. The system is applied through adhesive arrays placed on the abdomen and connected to a portable generator, and patients receive training on device placement and operation prior to use. Vincent Picozzi, MD, MMM, a medical oncologist and PANOVA-3 investigator, stated that the addition of Optune Pax improved overall survival without increasing systemic toxicity and significantly extended time to pain progression, noting that the therapy “has the potential to be practice changing.”
The device was generally well tolerated. Device-related skin adverse events occurred in 76% of treated patients and were predominantly grade 1 or 2. Serious adverse events were comparable between study arms, and no new safety signals were identified.
“This approval provides a novel, non-invasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings,” noted Michelle Tarver, MD, PhD, Director of the FDA’s Center for Devices and Radiological Health.
The PANOVA-3 results were published in Journal of Clinical Oncology.
Source: Novocure, US Food and Drug Administration, Cancer Stat Facts: Pancreatic Cancer