Approval covers the Tumor Treating Fields (TTFields) delivery technology for concomitant use with gemcitabine and nab-paclitaxel.
Optune Pax, a portable, therapeutic device, delivers TTFields non-invasively through wearable arrays. The alternating electrical feilds target the electrical properties of cancer cells to disrupt processes critical for cancer cell division and survival. This leads to cell death without significantly affecting healthy cells.
Small and lightweight, the device offers a wearable, portable option for continuing normal daily activities. The company designed it for enhanced carrying comfort and usability.
Optune Lua, the company’s version of the TTFields-delivering device, has FDA approval for treating non-small cell lung cancer (NSCLC). It picked up that approval in October 2024, then earned CE mark approval for NSCLC about six months later.
Novocure submitted its offeirng to the FDA for this pancreatic cancer indication in August 2025, then won Japanese approval the following month.
“The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer. Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness,” said Frank Leonard, CEO, Novocure. “Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells. This is a proud moment for Novocure and we look forward to bringing Optune Pax to patients and the healthcare providers who care for them.”
The study data that led to FDA approval for Novocure
Novocure used findings from the PANOVA-3 clinical trial to support approval. The trial evaluated Optune Pax with gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for locally advanced pancreatic cancer compared to gem/nab-pac alone.
PANOVA-3 enrolled 571 patients randomized 1:1 and followed for a minimum of 18 months. The trial met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with Optune Pax.
Investigators reported an mOS of 16.2 months for the Optune Pax group, compared to 14.2 months for the control, marking a two-month improvement.
Secondary endpoints included one-year survival rate, with a significant improvement for those using Optune Pax (68.1% compared to 60.2%). Additionally, time to pain progression came in at 15.2 months for Optune Pax, compared to a median of 9.1 months. The company labeled that 6.1-month extension a significant difference.
Treatment with Optune Pax and gem/nab-pac resulted in longer deterioration-free survival in global health status, pain, pancreatic pain and most of the digestive problems. Similar trends were observed for emotional function and fatigue/lack of energy.
Investigators described Optune Pax as well-tolerated with no new safety signals observed. Serious adverse events proved comparable between study arms. Most Optune Pax-treated patients (76.3%) experienced expected device-related skin adverse events under the arrays. The most common device-related adverse event not related to skin adverse events was fatigue, reported in 14 participants.
No device-related adverse events led to death and the study had no unanticipated device-related safety issues.
