FDA Approves First New Mesothelioma Therapy in 15 Years

Doctors administer treatment to a sick patient.

For the first time in 15 years, there is a new FDA-approved treatment for mesothelioma patients — the NovoTTF medical device.

Until now, mesothelioma patients haven’t had many treatment options — especially those who have stopped responding to the options available.

The last FDA-approved mesothelioma treatment was pemetrexed, known by its brand name, Alimta®. Alimta was approved as a combination chemotherapy drug in 2004.

Now, thanks to the Humanitarian Device Exemption (HDE), the NovoTTF system has been approved as a treatment for mesothelioma patients.

This device is designed to be used by patients who cannot have extensive surgeries or other therapies. The NovoTTF device works with the combination of chemotherapy drugs to disrupt the division of the mesothelioma cells.

NovoTTF Gives Hope to Patients With Limited Treatment Options

Many mesothelioma patients are not good candidates for aggressive, life-extending surgeries. Instead, these patients receive palliative care, including small surgeries, chemotherapy, and radiation, to ease their pain and other symptoms.

Other patients stop responding to the only FDA-approved first-line chemotherapy combination — Alimta and cisplatin. When they stop responding to this option, there are few avenues left.

Outside of palliative measures, patients may elect to enroll in a clinical trial. However, not everyone is comfortable participating in studies.

NovoTTF is changing this landscape. Now patients who have stopped responding to the standard chemotherapy or who are ineligible for surgery have another approved option. They can be hooked up to the NovoTTF and have another chance to improve their survival.

About NovoTTF Medical Device for Mesothelioma

The NovoTTF is a small, portable medical device. It has a tumor treatment field (TTF) generator, batteries, transducer arrays, and a power supply in case the individual doesn’t want to use the battery.

The transducer arrays are small insulated ceramic pads that stick to the patient’s chest and back. The whole system can be carried around in a small backpack.

The TTF generator causes electrical signals that pass through the transducer arrays and create electric fields — the TTF — in the patient’s chest. The TTF is tuned to frequencies that stop cancer cells from dividing. This, in turn, prevents the cancer cells from multiplying and causes them to die.

Patients in the final study that earned the NovoTTF its FDA-approval wore the device for 18 hours a day. They continued wearing the device until it was either unsafe to do so, or the device stopped working, and the patient’s mesothelioma began to progress.

While NovoTTF will allow many more patients to seek out treatments if they are ineligible for surgery, it is not for everyone.

Patients cannot have an implanted electronic medical device such as a pacemaker or automatic defibrillator. Patients also cannot have a sensitivity to conductive hydrogels, which are used to help the pads stick to the body.

The NovoTTF system can irritate the skin and cause rashes or blisters. However, the irritations can stop by relocating the pads, using a steroid cream or by stopping using the device.

Clinical Trial Results Show Improved Overall Survival

According to the most recent clinical trial, when the NovoTTF was used with chemotherapy, the average survival rate for all of the participants was 18.2 months. The average survival rate for mesothelioma patients is between 6 and 12 months.

To further test its effectiveness at increasing survival, the researchers divided the patients based on their mesothelioma cell type — epithelioid, sarcomatoid or biphasic (mixed). After being divided into groups by cell type, the average survival rate changed.

Patients with epithelioid cell type had their median survival rate increase to 21.2 months. For patients with non-epithelioid cell types, the survival rate dropped to 12.1 months.

More than half of the patients were still alive after 1 year of treatment. And, the average length of time before the mesothelioma started to grow again (recurrence) was 7.6 months.

These results show an improved survival rate. Without using NovoTTF, the average survival rates for late stages of mesothelioma was around 8 months.

Mesothelioma Patients Can Access Life-Extending Treatments

The news of the NovoTTF being approved by the FDA is a sign of hope for many patients who may have been told their treatment options are limited.

For the best chance at extending survival, mesothelioma patients must seek treatment from experienced specialists who can prescribe new and emerging treatments and therapies like the NovoTTF.

Mesothelioma patients are victims of asbestos exposure, and many are eligible for financial compensation to pay for life-extending treatments, like NovoTTF. To learn more about legal compensation options for you and your family, contact our Justice Support Team today. We’re available to answer your questions and review your claim.

Author:Stephanie Kidd

Editor-in-Chief of the Mesothelioma Justice Network

Stephanie Kidd

Stephanie Kidd works tirelessly as a dedicated advocate for the vulnerable and underrepresented. Stephanie worked as a copywriter for an agency whose focus was communicating safety procedures on construction work sites. With her extensive background in victim advocacy and a dedication to seeing justice done, Stephanie works hard to ensure that all online content is reliable, truthful and helpful.

Last modified: August 8, 2019

View 4 Sources
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