NovoTTF™-100L System - H180002
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: NovoTTF™-100L System
HDE Applicant: Novocure, Ltd.
Address: Topaz Building, P.O.Box 15022, MATAM Center Haifa, 3190500, Israel
Approval Date: May 23, 2019
Approval Letter: Approval Order
What is it? The NovoTTF-100L System is the first device indicated to be used in conjunction with a standard two-drug chemotherapy to treat patients with a cancerous tumor, malignant pleural mesothelioma (MPM) that is unable to be removed via surgery (unresectable).
The NovoTTF-100L System is a portable device that consists of a generator, transducer arrays (insulated ceramic discs), connection cables, power supply, carrying bag, battery, and battery charger. Transducer arrays connected from the device to a patients’ chest deliver the treatment to the patient. Patients are prescribed the device for use at home by a licensed physician who is trained to use the device, and can train patients and caregivers to use the device, and monitor patients under their care.
How does it work? The NovoTTF-100L System produces alternating electrical fields, called tumor treatment fields (“TTFields”) within the torso. TTFields are applied to the patient by adhesive bandages that hold transducer arrays. The transducer arrays are believed to disrupt the rapid cell division of cancer cells, inhibiting tumor growth and causing affected cancer cells to die. Patients use the device at home for at least 18 hours a day (with minimal breaks) until disease progression or in the absence of significant toxicity. The device is plugged into a power supply or uses the rechargeable battery when a patient wants to move around while wearing the device. Patients do not need to change any of the device’s settings in order to use it.
When is it used? A licensed physician may prescribe the NovoTTF-100L System to treat a patient with malignant pleural mesothelioma (called “MPM”) which cannot be cured with surgery or radiation. The NovoTTF-100L System is a treatment option used in addition to chemotherapy.
The NovoTTF-100L System is used for the treatment of adult patients with unresectable, locally advanced and metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.
What will it accomplish? A clinical trial of 80 patients with unresectable MPM who used the NovoTTF-100L System along with a standard 2-drug chemotherapy regimen was conducted. The median overall survival for patients was ~18 months. The data showed that the NovoTTF-100L System has the potential to extend life expectancy in this patient population.
In the clinical trial, the most common complication of using the device (in 57 of 80 patients) included skin irritation, red rash, and small sores or blisters on a patient’s skin where the transducer arrays attached to the chest. Patients with mild-to-moderate skin irritation were treated with steroid cream and by relocating the transducer arrays to other parts of the chest or back. Four (4) patients reported severe skin problems. In all cases of severe skin problems, the rash went away after stopping treatment.
When should it not be used? The NovoTTF-100L System should not be used in patients who have:
- an implanted electronic medical devices, such as a pacemaker or automatic defibrillator
- a sensitivity to conductive hydrogels like the gel used in electrocardiogram (ECG) stickers or electrical nerve simulation (TENS) electrodes
Additional information (including warnings, precautions, and adverse events):