FDA Approves Novocure's Electric Field Therapy for Locally Advanced Pancreatic Cancer

The U.S. Food and Drug Administration has approved Novocure's Optune Pax device for treating locally advanced pancreatic cancer, marking the first new treatment for this patient group in decades. The device was authorized through the agency's premarket approval pathway based on a trial demonstrating statistically significant survival benefits.

Novocure has developed technology that uses alternating electric fields, known as Tumor Treating Fields (TTF), to disrupt the proliferation of cancer cells. These low-intensity electric fields interfere with critical cellular processes required for rapid cancer cell division, targeting tumors while largely sparing healthy tissue.

In a study involving 571 patients with locally advanced pancreatic cancer, researchers compared standard chemotherapy alone with chemotherapy plus Tumor Treating Fields therapy. The combination arm achieved a median overall survival of 16.2 months, compared with 14.2 months in patients who received chemotherapy alone. This two-month difference met the trial's primary endpoint and reached statistical significance. The survival rate after a year was 68% for the group given the combined treatment versus 60% for the group treated with chemotherapy only.

However, the device did not improve progression-free survival or overall response rate. Nevertheless, patients receiving Tumor Treating Fields experienced significantly longer pain-free survival—15.2 months versus 9.1 months in the control group. Company leadership emphasized that pain-free survival represents one of the most meaningful clinical endpoints for patients, particularly in pancreatic cancer, where symptom burden is substantial. Patients reported a better quality of life in several additional ways.

For pancreatic cancer, clinicians apply adhesive patches to the torso. These patches generate electric fields that penetrate abdominal tissues to reach the tumor. The therapy is administered in combination with the chemotherapy agents gemcitabine and nab-paclitaxel.

The approval targets approximately 15,000 patients annually in the United States with locally advanced pancreatic cancer, making the opportunity slightly larger than the company's core brain cancer business. Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S.

Securing approval for locally advanced pancreatic cancer marks the first step in a broader expansion strategy within this tumor type. Novocure plans to release top-line data in the first quarter of 2026 from a trial evaluating Tumor Treating Fields in first-line metastatic pancreatic cancer.

The FDA first approved a device based on this technology, NovoTTF-100A, to treat glioblastoma multiforme (GBM), an aggressive form of brain cancer, in 2011. Subsequent authorizations expanded the eligible GBM population and authorized updated versions of the technology. In GBM, clinicians administer therapy by applying adhesive arrays containing insulated ceramic discs directly to the patient's shaved scalp. These arrays deliver electric fields through the skull to the tumor site.

The company won approval in mesothelioma in 2019 and in metastatic non-small cell lung cancer in 2024, but GBM remains its main indication. Optune Lua, the mesothelioma and NSCLC device, accounted for $3.5 million of the $174.4 million in sales that the company reported in its preliminary fourth-quarter results.

According to its preliminary results, Novocure had revenue of $655 million last year, 8% more than in 2024. The company has $448 million cash, after repaying a $561 million bond in November. The company's share price rose by more than 24% following the approval announcement. Its market cap at the current price is $1.5 billion.