FDA Approves Novocure's Optune Pax for Locally Advanced Pancreatic Cancer

The US Food and Drug Administration has approved Novocure's Optune Pax, a wearable device that delivers alternating electric fields to the abdomen, for adults with locally advanced pancreatic cancer, the agency said in a February 12 announcement. The device is used together with the chemotherapy drugs gemcitabine and nab-paclitaxel.

The FDA called Optune Pax "a first-of-its-kind device" and said it was approved through the premarket approval (PMA) pathway. Novocure, which announced the decision on February 11 in a press release filed with the SEC as an exhibit to a Form 8-K, said it is the first treatment approved by the FDA in nearly 30 years for locally advanced pancreatic cancer.

How the device works

The therapy, known as tumor treating fields (TTFields), is delivered through electrically insulated adhesive patches placed on the skin and connected to an electric field generator, according to the FDA. The agency said the treatment settings are preset by the manufacturer and cannot be adjusted by the patient or physician. Patients are trained to recharge and replace batteries, position the patches and replace the transducer arrays at least twice a week, and the generator is carried in a bag so treatment can continue during daily activities.

The FDA said TTFields work by physically disrupting the rapid cell division characteristic of cancer cells while minimizing damage to healthy tissue. The agency granted Optune Pax breakthrough device designation in December 2024.

The PANOVA-3 results

The FDA said its decision rested on a randomized, controlled pivotal study conducted under an investigational device exemption, which followed patients for up to five years, and that adding TTFields to gemcitabine and nab-paclitaxel improved overall survival by about two months compared with chemotherapy alone.

Novocure reported the details. Its Phase 3 PANOVA-3 trial enrolled 571 patients, randomized 1:1, as a first-line treatment. In the intent-to-treat population, median overall survival was 16.2 months for patients given Optune Pax with chemotherapy (285 patients) against 14.2 months for chemotherapy alone (286 patients), a hazard ratio of 0.82 (p=0.039), according to the company. The one-year survival rate was 68.1% against 60.2%.

The company also reported a median time to pain progression of 15.2 months with the device against 9.1 months without it. It said there was no significant difference between the arms in progression-free survival, local progression-free survival, objective response rate or tumor resectability. The trial results were published in the Journal of Clinical Oncology, Novocure said.

On safety, the FDA said localized skin reactions were the most common device-related risks. Novocure reported device-related skin adverse events under the arrays in 76.3% of treated patients, mostly grade 1 or 2, with 7.7% experiencing a grade 3 or higher event. The most common device-related event not involving the skin was fatigue, in 5.1% of participants, the company said.

"Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options," said Michelle Tarver, director of the FDA's Center for Devices and Radiological Health. Novocure chief executive Frank Leonard said in the company's release: "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."