FDA Approves Wearable Device to Treat Pancreatic Cancer

he FDA has approved a first-of-its-kind wearable electrical device — Optune Pax (Novocure) — for patients with locally advanced pancreatic cancer, in combination with gemcitabine and nab-paclitaxel.

Optune Pax delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by disrupting the rapid cell division characteristic of cancer cells, causing cell death.

Swiss-based maker Novocure said the approval is the first for locally advanced pancreatic cancer in nearly 30 years.

To use the device, patients wear electrically insulated adhesive patches that are placed on the abdomen and connected to an electric field generator, which is carried in a specially designed bag. They are trained in 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.

Approval was based on the PANOVA-3 trial which randomized 571 patients to gem/nab-pac alone or with TTFields. There was no difference between the groups in progression-free survival, but median overall survival was 16.2 months with TTFields add-on vs 14.2 months. Pain-free survival was also longer, at 15.2 months vs 9.1 months. 

In the modified per protocol population — defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac arm or at least one complete cycle of gem/nab-pac — patients treated with Optune Pax and gem/nab-pac had a median overall survival of 18.3 months vs 15.1 months with gem/nab-pac alone.

Localized skin reactions were the most common device-related risks observed in the study, occurring in about three-quarters of patients, including 7.7% with grade 3 or higher events.

Novocure’s TTFields system carries previous indications for glioblastoma, metastatic mesothelioma, and metastatic non-small cell lung cancer.

The cost, roughly $21,000 per month, is comparable to many oncology drugs and covers equipment rental, replacement arrays and supplies, and support services such as help with insurance coverage and adherence monitoring.

Novocure is investigating TTFields in a wide range of additional tumors, including breast, colorectal, renal, and cervical cancer.