Approximately 3,000 people are diagnosed with mesothelioma each year, and some may be here in Ohio. At present, no cure for this condition exists, but patients can undergo traditional cancer treatments in an attempt to prolong their lives. Even so, researchers, including medical device and pharmaceutical companies, are working to find new treatments that could further extend the lives of patients with mesothelioma.
To that end, Novocure wants to seek approval from the Food and Drug Administration to begin a phase 2 trial of an electric field device to treat cancer tumors. The company wants to market the device for mesothelioma under the FDA’s humanitarian device exception. This exception does not get used often, but is meant to encourage research in the field of rare diseases. The evidence requirements are lower and only apply to diseases that affect 8,000 people or less per year throughout the United States.
The device in question is intended to disrupt cancer-cell division through the use of alternating electric fields. Even though the company intends for the device to be used in the treatment of other cancers, it believes that using it for mesothelioma patients could get the device to market faster. In the meantime, it is possible that patients with this asbestos-related disease could reap some benefit from the use of the device.
Receiving a diagnosis of mesothelioma can be devastating. With limited treatment options and dire prognoses for this type of cancer, it might be attractive to some patients here in Ohio to participate in an experimental treatment. The problem is that too many families lose — or will lose — their loved ones long before they have a chance to participate in medical studies. When that happens, it may be possible to pursue restitution against one or more parties who may bear some legal liability in the loss of a loved one exposed to asbestos. These types of wrongful death claims often become complex rather quickly, and it may be beneficial to enlist the advice and aid of an attorney experienced in these types of cases.
Source: fiercebiotech.com, “Novocure plans FDA filing as anti-cancer device clears phase 2“, Nick Paul Taylor, April 18, 2018