FDA Approves First New Treatment for Mesothelioma in 15 Years

Treatment & Doctors
Reading Time: 4 mins
Publication Date: 05/24/2019
Fact Checked
Our fact-checking process begins with a thorough review of all sources to ensure they are high quality. Then we cross-check the facts with original medical or scientific reports published by those sources, or we validate the facts with reputable news organizations, medical and scientific experts and other health experts. Each page includes all sources for full transparency.
Reviewed

Asbestos.com is the nation’s most trusted mesothelioma resource

The Mesothelioma Center at Asbestos.com has provided patients and their loved ones the most updated and reliable information on mesothelioma and asbestos exposure since 2006.

Our team of Patient Advocates includes a medical doctor, a registered nurse, health services administrators, veterans, VA-accredited Claims Agents, an oncology patient navigator and hospice care expert. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey.

More than 30 contributors, including mesothelioma doctors, survivors, health care professionals and other experts, have peer-reviewed our website and written unique research-driven articles to ensure you get the highest-quality medical and health information.

About The Mesothelioma Center at Asbestos.com

  • Assisting mesothelioma patients and their loved ones since 2006.
  • Helps more than 50% of mesothelioma patients diagnosed annually in the U.S.
  • A+ rating from the Better Business Bureau.
  • 5-star reviewed mesothelioma and support organization.
Learn More About Us

Testimonials

"My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. This is a staff of compassionate and knowledgeable individuals who respect what your family is experiencing and who go the extra mile to make an unfortunate diagnosis less stressful. Information and assistance were provided by The Mesothelioma Center at no cost to our family."
Lashawn
Mesothelioma patient’s daughter
  • Google Review Rating
  • BBB Review Rating

How to Cite Asbestos.com’s Article

APA

Mauney, M. (2022, August 22). FDA Approves First New Treatment for Mesothelioma in 15 Years. Asbestos.com. Retrieved February 8, 2023, from https://www.asbestos.com/news/2019/05/24/fda-approves-new-mesothelioma-treatment/

MLA

Mauney, Matt. "FDA Approves First New Treatment for Mesothelioma in 15 Years." Asbestos.com, 22 Aug 2022, https://www.asbestos.com/news/2019/05/24/fda-approves-new-mesothelioma-treatment/.

Chicago

Mauney, Matt. "FDA Approves First New Treatment for Mesothelioma in 15 Years." Asbestos.com. Last modified August 22, 2022. https://www.asbestos.com/news/2019/05/24/fda-approves-new-mesothelioma-treatment/.

The U.S. Food & Drug Administration on Thursday approved Tumor Treating Fields, a therapy involving electric currents that disrupt cancer cell division and inhibit tumor growth, for the first-line treatment of malignant pleural mesothelioma.

It is the first new treatment for mesothelioma in more than 15 years that the FDA has approved. In 2004, the agency added the chemotherapy drug pemetrexed (Alimta) to standard-of-care treatment.

The FDA approved Novocure’s NovoTTF-100L System under the agency’s Humanitarian Device Exemption. The approval comes eight months after Novocure, which manufactures and markets the device, released results from its STELLAR phase II clinical trial.

The Tumor Treating Fields delivery system is now FDA approved in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM).

It is a major breakthrough for the rare cancer caused by asbestos exposure. Only 10% to 20% of mesothelioma patients qualify for tumor-removing surgery.

“Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer,” Bill Doyle, Novocure’s executive chairman, said in a press release. “FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure.”

Brigham and Women's Hospital and the Lung Institute at Baylor College of Medicine
Find a Mesothelioma Cancer Center
Access top mesothelioma cancer centers that have experience treating this rare disease.

How NovoTTF-100L Works

Tumor Treating Fields is a relatively new technology that has gained traction as a treatment for some of the most aggressive cancers.

NovoTTF-100L uses low-intensity alternating electric fields, which are tuned to interfere with the division of cancer cells. For mesothelioma, the currents are delivered noninvasively to the upper torso.

The system is intended for continuous home use by mesothelioma patients.

In 2011, the FDA approved Optune, another Tumor Treating Fields device, under the Premarket Authorization pathway for the treatment of glioblastoma, the most aggressive form of brain cancer.

“Our mission is to improve patients’ survival without the toxicity you get with systemic chemotherapy,” Dr. Eilon Kirson, chief science officer at Novocure, told The Mesothelioma Center at Asbestos.com in September 2018.

NovoTTF-100L System for mesothelioma
The components of Novocure’s NovoTTF-100L Tumor Treating Fields System, which is now approved as a first-line treatment for malignant pleural mesothelioma.

Approval Comes After STELLAR Results

Novocure’s STELLAR clinical trial saw significant survival benefits for pleural mesothelioma patients who used Tumor Treating Fields in combination with standard chemotherapy.

Patients treated with the system survived six months longer than patients receiving only chemotherapy. There were no reported cases of major side effects or system toxicity.

  • Tumor Treating Fields Plus Chemo: 18.2-month overall survival
  • Alimta and Either Cisplatin or Carboplatin Only: 12.1-month overall survival

More than 97% of patients saw a clinical benefit, which includes either partial response or stable disease.

The median overall survival for patients with epithelioid mesothelioma — the most common mesothelioma cell type — was 21.2 months. Patients with sarcomatoid or biphasic cell types survived an average of 12.1 months.

Patients in the Tumor Treating Fields group saw a progression-free survival of 7.6 months, compared to 5.7 months for the chemotherapy only group.

Skin irritation was the most reported side effect from the NovoTTF-100L system, seen in 46% of patients. But only 4% reported grade 3 skin irritation.

The clinical trial, held at cancer centers across Europe, included 80 patients with unresectable, previously untreated, malignant pleural mesothelioma. The results were presented in September 2018 at the 19th annual World Conference on Lung Cancer.

“It’s not the cure we’re all looking for, but it means that some patients are seeing a significant benefit,” Kirson said. “It’s a jump forward. It can change the outcome of this disease, make it that much less horrific.”

open book icon vector illustration
Medically Reviewed by Top Mesothelioma Doctors
Free Mesothelioma Guide