The U.S. Food and Drug Administration (FDA) recently approved a new therapy indicated for the treatment of mesothelioma. Using electric currents rather than toxic chemotherapy drugs, the therapy can inhibit tumor growth. The last new treatment approved by the FDA specifically for treatment of this type of cancer was the chemotherapy agent pemetrexed in 2004. The new approval gives patients living with this difficult cancer new hope.
Clinical Success with Tumor Treating Fields
The medical device approved for mesothelioma treatment is known as the NovoTTF-100L System, or the Tumor Treating Fields System. Made and tested by Novocure, the device received approval under the FDA’s Humanitarian Device Exemption. This exemption allows for quicker and easier approval of a device that may benefit patients with rare diseases, like mesothelioma.
The approval came on the heels of Novocure’s phase II clinical trial known as STELLAR. Usually, new treatments are not approved until several more phases have proven it to be safe and effective. In the phase II trial, nearly 100 percent of participants saw benefits from the Tumor Treating Fields System.
Clinical results were positive, with survival times of 12 months for patients who received only chemotherapy and 18 months for those who received chemotherapy along with the new treatment. The System also did not seem to cause any major adverse events in participants. Mild skin irritation was most common.
How the New Treatment Works
The NovoTTF-100L makes use of alternating electrical fields of low intensity to disrupt tumor growth. Researchers believe that the electrical fields and currents at specifically tuned frequencies interfere with how cancer cells divide. Disrupting this process prevents tumors from getting bigger. The device is designed to be used by patients in their own homes.
Similar therapies have already been used and approved in other types of cancer that are similarly aggressive and difficult to treat. The patients in Novocure’s phase II trial included 80 people with unresectable mesothelioma. This means that it could not be managed or treated with surgery, in most cases because the cancer had metastasized and spread throughout the body.
The Importance of New Treatments for Mesothelioma
Mesothelioma is a devastating type of cancer that is often diagnosed when it is too late to achieve remission. It is generally considered incurable and has a poor prognosis. Caused by exposure to asbestos in the vast majority of cases, mesothelioma is especially tragic because it is preventable.
Because the cancer is aggressive, grows as small, multiple tumors, and is mostly diagnosed in later stages, mesothelioma is difficult to treat. Chemotherapy, often combined with surgery or radiation therapy, is most often used as treatment. There are very few treatments, and just a couple of chemotherapy drugs that the FDA has approved for managing mesothelioma.
Patients living with this cancer and trying to fight it often turn to clinical trials with the hope that experimental therapies will give them a chance at extending their lives. This new treatment, the NovoTTF-100L System, is one of the few new therapies that have proven to do just that. Now, thanks to the FDA’s accelerated approval, more patients with mesothelioma have access to a low-risk, safe treatment that really could help.