Food and Drug Administration (FDA) has approved Novocure‘s NovoTTF device (called the NovoTTF-100A System) that is first-of-a-kind treatment that fights cancerous brain tumors using electrical energy fields. FDA approved the device for patients with aggressive brain tumors that have returned after treatment with chemotherapy and other interventions.
This is a big breakthrough, because till now, doctors have treated cancer using three methods – drugs, radiation and surgery. The device adds a 4th option to the treatment.
“The reason why this is so exciting is that we now have FDA approval of a totally new type of treatment for cancer,” said Dr. Herb Engelhard, an associate professor of neurosurgery at the University of Illinois in Chicago. Engelhard helped conduct the study of NovoTTF but received no compensation from the company.
“All of us as investigators were skeptical at first, but I have seen the scans and I believe this is killing cancer cells in patients,” Engelhard said.
The device is a 6-pound device that patients carry with them in a small bag. The electrical current is sent from the device to four electrodes which are attached to the patient’s shaved head. The electrical fields generated by the electrodes, disrupt the division of the cancer cell.
Results from a 237 patient randomized pivotal trial demonstrated that compared to patients treated with chemotherapy, NovoTTF treated patients achieved comparable median overall survival times, had fewer side effects, and reported improved quality of life scores.
Glioblastoma is the most aggressive and most common form of primary brain tumor in the United States. The disease affects approximately 10,000 Americans each year. The median overall survival time from initial diagnosis is 15 months with optimal therapy, and median survival from the time of tumor recurrence is only three to four months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.
The trial didn’t seem to extend life of the patients but improved the overall life quality – as the patients did not have the side effects of chemotherapy, such as nausea, diarrhea and infection.
A panel of outside advisers to the FDA narrowly voted 7-6 in favor of the effectiveness of the device last month. The FDA is not required to follow such recommendations, though it often does.
Congratulations to Novocure for the approval. Hopefully, the device will be extended to other kind of cancers as well.