Pancreatic cancer, minimally invasive patches and electric fields allied to the patient

Electrically insulated adhesive patches that are applied to the patient's skin and connected to an electric field generator: the US Food and Drug Administration has approved a device that the FDA itself describes as 'unique' for the treatment of adult patients with locally advanced pancreatic cancer. We are talking about a portable, non-invasive device that sends alternating electric fields, called 'tumour treatment fields' (TTFields), to the abdomen. These act 'by physically interrupting the rapid cell division characteristic of cancer cells, while minimising damage to healthy tissue,' the US Drug Authority explained.

The Optune Pax portable device is developed by Novocure and has been approved through the premarket pathway (Pma), the Fda's most rigorous review process for medical devices. The Agency's green light is based on data from a study conducted under an Investigational Device Exemption, a procedure that allows new medical devices to be tested in clinical trials, thus using them when these products have not yet been approved.

The technological parameters of the treatment are pre-set by the manufacturer and cannot be adjusted by the patient or doctor. But of course patients are trained on how to use the device, including how to recharge and replace the batteries, connect it to an external power supply, place the adhesive patches on the appropriate areas of the body and replace the transducer arrays at least twice a week. The device is designed to be worn with the generator carried in a specially designed bag, allowing patients to receive continuous treatment while going about their normal daily activities.

The randomised controlled trial followed adult patients with locally advanced pancreatic cancer for up to five years. The results - as reported by the Fda - showed that the addition of TTFields to the standard of care chemotherapies gemcitabine and nab-paclitaxelo (GnP) improved overall survival by about two months compared to GnP alone. Localised skin reactions were the most common risks observed in the study. The results of which formed the basis for the Fda's decision on approval of Pma: the 'breakthrough device' designation came in December 2024, branding Optune Pax as a 'breakthrough' therapy, capable of substantially changing the course of the disease.

Giving the scope of the breakthrough in the management of the disease - which accounts for about 3.3% of new cancer cases in the US but takes up a disproportionately large share of cancer deaths due to late diagnosis, aggressive disease behaviour and limited treatment options - is Fda Commissioner Marty Makary: "Having treated many patients with this cancer, I know how difficult diagnosis can be. The pancreatic cancer community deserves better treatment options,' he said. The Fda is working tirelessly to bring potentially promising therapies to those who need them.