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FDA premarket approval · Novocure · Oncology

Optune Pax

A wearable Tumor Treating Fields device for locally advanced pancreatic cancer.

CompareFDA press release
Approved · PMABreakthrough device

Optune Pax

Novocure · Oncology · First-of-its-kind device for pancreatic cancer

Type
Therapy device
FDA route
Premarket approval (PMA)
Setting
Home
Used by
Patients, after training
Bottom line for your practice
45s read

Adults with locally advanced pancreatic cancer have a wearable device option; in the pivotal study, adding it to gemcitabine and nab-paclitaxel improved overall survival by approximately two months. The device is designed to be worn during normal daily activities, and patients are trained to operate it themselves.

What it is
A portable, non-invasive device that delivers alternating electrical fields, called tumor treating fields (TTFields), to the abdomen through electrically insulated adhesive patches connected to a field generator. TTFields work by physically disrupting the rapid cell division characteristic of cancer cells.
Indicated for
Adult patients with locally advanced pancreatic cancer.
What changes
The pivotal study compared TTFields added to standard of care chemotherapy (gemcitabine and nab-paclitaxel) against that chemotherapy alone.
Evidence
Open-label randomized trialStudy not named in the releaseAdding TTFields to gemcitabine and nab-paclitaxel improved overall survival by approximately two months compared with gemcitabine and nab-paclitaxel alone. The release does not give the number of patients.Randomized, but patients and clinicians knew the assignment, so subjective outcomes are more open to bias.
Watch for
Localized skin reactions were the most common device-related risks in the study. Treatment parameters are preset by the manufacturer and cannot be adjusted by the patient or physician, and transducer arrays must be replaced at least twice per week.
Training
Patients are trained to use the device, including recharging and replacing batteries, connecting external power, placing the adhesive patches and replacing the transducer arrays at least twice per week.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.Breakthrough Device designation: for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

Clinical summary

A portable, non-invasive device that delivers alternating electric fields (Tumor Treating Fields) to the abdomen to disrupt cancer cell division, worn alongside gemcitabine plus nab-paclitaxel in adults with locally advanced pancreatic cancer. In the PANOVA-3 trial it extended overall survival by about two months over chemotherapy alone. Skin reactions under the transducer arrays were the most common device-related adverse event.

From the source 8

FDA press release

The FDA press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer.

    Backs · First claim; indication

  2. Optune Pax was approved through the premarket approval (PMA) pathway, the FDA’s most rigorous review process for medical devices.

    Backs · Pathway: PMA

  3. The FDA granted Breakthrough Device designation for the Optune Pax device in December 2024.

    Backs · Breakthrough Device designation

View all 8 lines

  1. The randomized and controlled study followed adult patients with locally advanced pancreatic cancer for up to five years.

    Backs · Randomized and controlled study

  2. The results showed that the addition of TTFields to standard of care chemotherapies gemcitabine and nab-paclitaxel (GnP) improved Overall Survival by approximately two months compared to GnP alone.

    Backs · Overall survival improved by approximately two months

  3. Localized skin reactions were the most common device-related risks observed in the study.

    Backs · Skin reactions

  4. Device treatment technological parameters are preset by the manufacturer and cannot be adjusted by the patient or physician.

    Backs · Preset parameters

  5. 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.

    Backs · Training; arrays replaced at least twice per week

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