FDA approves new medical device for form of brain cancer

The u.s. Food and Drug Administration recently approved the NovoTTF-100a system, a new device for the treatment of adults with glioblastoma multiforme (GBM) who returns or progresses after receiving chemotherapy and radiation.

Brain tumors are the growth of abnormal cells in the brain tissue. According to the National Cancer Institute, each year about 19,000 people in the United States are diagnosed with primary brain cancer. In 2010, there were 13,140 killing of brain and other nervous system cancers in the United States.

GBM is the most common primary brain cancer. The brain tumor is highly resistant to standard treatments such as surgery, radiation and chemotherapy.

When using the NovoTTF-100a system, a professional health care electrodes on the surface of the patient's scalp sites to deliver low-intensity, electrical fields change "tumor treating fields" mentioned (TTFs) to the site of the tumor. The unique shape and electrical characteristics of tumor cells to share those prone to damage when exposed to TTF, which could stop tumor growth.

The device is portable and can be powered with batteries or connected to a power outlet. Patients can use the device at home, causing them to their normal daily activities.

"Recurrent glioblastoma multiforme is a devastating form of brain cancer that often eludes standard treatments," said Jeffrey Shuren, M.D., J.D., Director of the FDA Center for devices and radiological health. "The approval of the Agency of the NovoTTF-100a system shows FDA commitment to innovative new devices that patients with other treatment options."

The FDA approval of the NovoTTF 100a system based on results of a single international clinical study in 237 patients with recurrent GBM or with GBM that didn't had responded to traditional therapy. Patients in the study were randomly assigned to both NovoTTF-100a System or chemotherapy treatment.

The study showed comparable overall survival between patients treated with the NovoTTF-100a system and those who underwent chemotherapy.

Patients treated with the NovoTTF-100a system experienced a slightly higher incidence of neurological side effects including convulsions and headaches compared to patients receiving chemotherapy. She has not, however, the significant side effects associated with chemotherapy, including nausea, anemia, fatigue and severe infections experience.

A survey of patients in the study proposed a better quality of life in the NovoTTF-100a recurrent GBM patients compared with patients receiving chemotherapy.

Patients should not the NovoTTF-100a system use if they have an implanted medical device, or a skull defect, or have a known sensitivity to conductive hydrogels, such as that are used with electrocardiograms. The NovoTTF-100a system is not intended to be used in combination with other cancer treatment. The device should be used only after other treatments have failed.

The NovoTTF-100a system is made up of Novocure of Portsmouth, NH

Source: U.S. Food and Drug Administration