FDA Approves Device for Treating Locally Advanced Pancreatic Cancer at Home

The FDA has approved a device, Optune Pax, for treating adult patients with locally advanced pancreatic cancer.

The device, developed by Novocure, is a “portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.” The approval also aligns with the FDA’s “Home as a Health Care Hub Initiative, which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people’s daily lives at home.”

Pancreatic cancer was expected to “result in approximately 67,440 new diagnoses and 51,980 deaths in the U.S. in 2025. Pancreatic cancer accounts for roughly 3.3% of all new cancer cases but represents a disproportionately large share of cancer deaths due to its late detection, aggressive disease behavior, and limited treatment options.”

Patients are trained on how to use the device, “including how to recharge and replace device batteries, connect the device to an external power supply, place the adhesive patches in the appropriate positions on the body, and replace the transducer arrays at least twice per week.” It was approved through the “premarket approval (PMA) pathway, the FDA’s most rigorous review process for medical devices. The FDA’s approval of Optune Pax is based on data from a pivotal clinical study conducted under an Investigational Device Exemption.”