FDA approves electrical field therapy Optune Pax for pancreatic cancer
Portable device shown to boost survival rates, slow pain progression
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The U.S. Food and Drug Administration (FDA) has approved Novocure’s Optune Pax, a type of Tumor Treating Fields (TTFields) therapy, as a treatment for locally advanced pancreatic cancer.
The approval specifically covers the use of Optune Pax in combination with the chemotherapy regimen gemcitabine and nab-paclitaxel, and was based on results from the Phase 3 PANOVA-3 (NCT03377491) trial. PANOVA-3 showed that, compared to chemotherapy alone, adding Optune Pax increased patients’ survival, and resulted in fewer symptoms and more manageable side effects.
“The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer,” Frank Leonard, Novocure’s CEO, said in a company press release. “Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells … and we look forward to bringing Optune Pax to patients and the healthcare providers who care for them.”
Optune Pax targets cancer cells’ electrical properties
Pancreatic cancer is a type of cancer that begins in the pancreas, an organ involved in digestion and blood sugar control, causing symptoms such as abdominal pain, jaundice (yellowing of the skin or whites of the eyes), nausea, and fatigue. In many cases, when symptoms become obvious, cancer has already affected other organs.
“Survival rates for pancreatic cancer have seen only modest improvements over time and treatment advances have remained limited, underscoring how challenging this disease is to treat,” said Anna Berkenblit, MD, chief scientific and medical officer at the Pancreatic Cancer Action Network.
Optune Pax delivers TTFields, or low-intensity alternating electric fields, which target the electrical properties of cancer cells and disrupt processes critical for cancer cell division and survival, without significantly affecting healthy cells.
The treatment is administered via adhesive patches placed on a patient’s skin, connected to a portable device that generates electric fields. The technological parameters are preset by the manufacturer. Patients are trained to use the device, which is carried in a specially designed bag, allowing patients to receive continuous treatment while performing their daily activities.
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.
The PANOVA-3 study enrolled 571 patients with pancreatic cancer who could not receive surgery, and who were randomly assigned to receive first-line treatment with Optune Pax plus standard chemotherapy (gemcitabine and nab-paclitaxel), or chemotherapy alone.
The trial met its primary endpoint, demonstrating that patients treated with Optune Pax and chemotherapy lived two additional months compared to chemotherapy alone (16.2 vs. 14.2 months). More participants in the Optune Pax group also lived past a year (68.1% vs. 60.2%).
The increase was greater in the subset of patients who more strictly adhered to the treatment protocol, in whom Optune Pax increased survival by 3.2 months (18.3 vs. 15.1 months). A larger proportion of thsi group (75.2%) also lived for more than one year compared to the chemotherapy-only group (65.9%).
Patients receiving Optune Pax combined with chemotherapy experienced a 6.1-month longer delay in worsening pain (15.2 vs. 9.1 months) and showed a slower decline in pain- and digestion-related quality of life.
“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,” Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, said in an FDA press release.
