FDA Approves Novocure’s Optune Pax Wearable Device for Pancreatic Cancer

Optune Pax delivers low-intensity alternating electric fields through adhesive arrays placed on the abdomen, which disrupt critical proteins involved in mitosis, impair the formation of the mitotic spindle and lead to cancer cell death.

The U.S. Food and Drug Administration has approved Optune Pax, a wearable device developed by Novocure, for adults with locally advanced pancreatic cancer.

Used alongside gemcitabine and nab-paclitaxel, the device employs tumour-treating fields (TTFields) to interfere with cancer cell division and extend survival.

The approval of Optune Pax has been based on findings from the Phase 3 PANOVA-3 trial, which enrolled 571 patients and compared standard chemotherapy alone with chemotherapy plus TTFields therapy.

In the intent-to-treat population, median overall survival reached 16.2 months in the Optune Pax arm versus 14.2 months in the control group. The combination also extended median time to pain progression to 15.2 months, compared with 9.1 months for chemotherapy alone. In a modified per-protocol analysis, overall survival increased to 18.3 months with the device, versus 15.1 months without it.

“The approval of Optune Pax marks the first new treatment in nearly 30 years for patients fighting locally advanced pancreatic cancer,” said Novocure CEO Frank Leonard. “Our technology represents a fundamentally different approach, a biophysical one, that targets the electrical properties of cancer cells.”

Optune Pax delivers low-intensity alternating electric fields through adhesive arrays placed on the abdomen. These tumour-treating fields disrupt critical proteins involved in mitosis, including tubulin and septin, impairing the formation of the mitotic spindle and leading to cancer cell death.

Because the electrical frequencies are calibrated to affect rapidly dividing cells, healthy tissues are largely spared. Patients carry a portable field generator in a dedicated bag and are trained to manage battery replacement, array changes, and device maintenance.

Safety data from PANOVA-3 showed that the most frequent device-related events were localized skin reactions beneath the arrays, reported in about three-quarters of participants, with severe reactions occurring in fewer than 8 per cent.

Novocure has previously secured FDA approvals for TTFields in glioblastoma and mesothelioma, and continues to investigate the technology across other solid tumours.

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