Optune Pax concomitant with gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer
Novocure has announced that the U.S. Food and Drug Administration has approved Optune Pax for the treatment of adults with locally advanced pancreatic cancer when used together with gemcitabine and nab paclitaxel. The approval introduces a new option for patients facing one of the most aggressive and difficult to treat cancers.
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Optune Pax is a wearable, portable device that delivers Tumor Treating Fields, known as TTFields, through adhesive arrays placed on the body. These low intensity alternating electric fields are designed to interfere with the electrical processes that cancer cells rely on to divide and survive. By disrupting cell division, the therapy aims to slow tumor growth while limiting damage to healthy tissue.
The FDA decision is supported by findings from the Phase 3 PANOVA 3 clinical trial, an international, randomized, open label study that enrolled 571 patients. Participants received either standard chemotherapy alone or chemotherapy combined with Optune Pax as a first line treatment and were followed for at least 18 months. The study achieved its primary goal by demonstrating a statistically significant improvement in median overall survival for patients who received the device alongside chemotherapy.
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In the intent to treat population, patients treated with Optune Pax plus chemotherapy achieved a median overall survival of 16.2 months compared with 14.2 months for those receiving chemotherapy alone. In a modified per protocol analysis that included patients who met minimum treatment exposure requirements, median overall survival increased to 18.3 months in the Optune Pax group versus 15.1 months in the control arm. One year survival rates were also higher among patients treated with the device in both analyses.
Vincent Picozzi, M.D., MMM, medical oncologist and investigator in the PANOVA 3 trial, said the addition of Optune Pax led to a meaningful extension in overall survival without increasing the systemic side effects typically associated with chemotherapy. He explained that the therapy also delayed worsening pain, which is a major concern in pancreatic cancer care, and noted that maintaining quality of life is a central focus when treating these patients. He added that the approval could influence future treatment standards for locally advanced disease.
Pain control was another important outcome in the trial. Patients receiving Optune Pax experienced a median time to pain progression of 15.2 months compared with 9.1 months in the chemotherapy alone group, reflecting a significant delay in worsening symptoms. Quality of life was assessed using validated cancer specific questionnaires and results showed longer periods before deterioration in overall health status, pain, digestive symptoms, and several functional measures among patients treated with the device.
There were no significant differences between the two groups in progression free survival, local progression free survival, objective response rate, puncture free survival, or tumor resectability. The safety profile of Optune Pax was consistent with prior experience. The device did not increase chemotherapy related toxicities and no new safety concerns were identified. Most device related side effects involved skin irritation beneath the arrays, with the majority classified as mild to moderate. A small proportion of patients experienced more severe skin reactions. Fatigue was the most frequently reported non skin related device associated effect. No device related deaths occurred during the study.
Frank Leonard, CEO of Novocure, said the approval represents the first new treatment approach for this patient population in many years. He emphasized that traditional drug therapies often struggle to effectively penetrate pancreatic tumors and described Optune Pax as a fundamentally different strategy that uses a physical mechanism to target cancer cells. He stated that the company is proud to bring this option to patients and the clinicians who care for them.
Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN, said progress in pancreatic cancer has been limited and survival improvements have been modest over time. She described the approval as an important milestone for the community and highlighted the need for continued innovation in diseases where treatment choices remain scarce. According to her, the availability of a new approach for locally advanced pancreatic cancer offers hope to patients who urgently need additional options.
With FDA clearance now secured, Optune Pax becomes part of the frontline treatment landscape for adults with locally advanced pancreatic cancer, marking a significant development in the ongoing effort to improve outcomes in this challenging disease.
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