Pancreatic cancer: FDA approves Optune Pax wearable device

The FDA has approved Optune Pax, a wearable device that delivers electric fields for inoperable, locally advanced pancreatic cancer; clinical trial results reported roughly a two-month average survival benefit and a delay in pain.

The FDA has approved Optune Pax for inoperable, locally advanced pancreatic cancer, the first new treatment for this presentation in about 30 years. The device is a wearable system intended for use at home that delivers electric fields to interfere with dividing cancer cells. The agency granted expedited review for the technology in 2024 because of the seriousness of the disease. Clinical trial data reported an average survival gain of about two months and a significant delay in pain for study participants. What is known: - The FDA approved Optune Pax for patients with inoperable, locally advanced pancreatic cancer after an expedited review process. - Optune Pax is a wearable device worn for many hours daily that delivers electric fields aimed at disrupting dividing cancer cells. - In clinical testing, patients on the device had about two months longer average survival and experienced delayed pain compared with the comparison group. - The device will be made available to eligible patients while the technology continues to be tested for other cancer types, and questions about insurance coverage have been raised. Summary: The approval introduces a new option for people with inoperable pancreatic cancer and represents a modest advance in a disease with few recent treatment approvals. Ongoing studies and practical issues such as coverage and longer-term outcomes remain under review.