Tumor Treating Fields Approved by FDA

The FDA (US Food and Drug Administration) has approved a new treatment for patients as an alternative to chemotherapy. The promising new non-invasive treatment by Novocure uses "Tumor Treating Fields" (NovoTTF) to treat cancerous growths and is now available for adult patients with recurring brain tumors (recurrent glioblastoma or GBM). The treatment delivers electric fields to a patient utilizing a portable, wearable device that permits the patient to maintain normal daily activities without down time.

"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective," said Eilon Kirson, M.D., Ph.D., Novocure's Chief Medical Officer. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients and indirectly on their families."

According to Novocure, TTF therapy has several important aspects that distinguish it from existing cancer treatment methods.

1. TTF therapy is tuned to affect only one cell type at a time.  TTF therapy has not been shown to affect cells that are not undergoing division. 
2. TTF therapy is not expected to affect the normal functions of bone marrow in creating red and white blood cells, since the bone marrow is naturally shielded from the fields. 
3. TTF therapy is delivered locally through a physical, non-chemical pathway.  This allows TTF therapy to treat brain tumors, whereas other mitotic inhibitor treatments such as taxanes and vinca alkaloids have poor diffusion across the blood-brain barrier and are rarely used to treat brain tumors. 
4. There is no evidence of cumulative damage to healthy tissues in the body when exposed to TTF therapy.  Since the fields alternate so rapidly, they have no effect on normal quiescent cells nor do they stimulate nerves and muscles.

The Novocure device, which weighs about six pounds (three kg), is to be used continuously throughout the day by the patient. Tests indicate that the devices can slow and reverse tumor growth by inhibiting mitosis, the process by which cancerous cells divide and replicate. The NovoTTF treatment involves placing pads onto the patient's skin that creates a low intensity and alternating electric field within the tumor. The electric field prevents the normal mitotic process and causes cancer cell death prior to division without harming healthy cells. Whilst chemotherapy treatments can often be debilitating, the most commonly reported side effect from the NovoTTF treatment is a mild-to-moderate rash beneath the electrodes.

Glioblastoma is considered an aggressive and common form of primary brain cancer. In the United States the disease affects approximately 10,000 people each year. The results from a 237-patient trial indicated that NovoTTF treated patients achieved comparable median overall survival times to patients treated with chemotherapy but had fewer side effects, and reported an improved quality of life.

"In the lab we've observed tremendous synergies between chemotherapy and tumor treating fields," said Bill Doyle, Executive Chairman of Novocure. "We have more trails planned for lung cancer, pancreatic cancer, ovarian cancer and breast cancer. And I firmly believe that in the next ten years Tumor Treating Fields will be a weapon available to doctors and patients for all of these most difficult to treat solid tumors."

Tumor Treating Fields are discussed by Novocure executive, Bill Doyle at the TEDMed event this year.