FDA approves the NovoTTF-100a system for the treatment of patients with recurrent Glioblastoma Multiforme (GBM) brain tumors

Novocure announced that the u.s. Food and Drug Administration (FDA) approved the NovoTTF-100a System (NovoTTF) for the treatment of adult patients with brain tumors, glioblastoma multiforme (GBM), after tumor recurrence after chemotherapy. The portable, wearable device delivers an anti-mitotic, anti-cancer therapy patients maintain their normal daily activities. The NovoTTF is a novel, first-in-class treatment option for patients and doctors glioblastoma fight.

"Our device offers patients and physicians with a novel, non-invasive alternative to chemotherapy that safely and effectively," said Eilon Kirson, M.D., Ph.d., the Chief Medical Officer Novocure. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapy unbearable on recurring GBM patients and indirectly on their families."

Results of a 237 patient randomized Central trial demonstrated that in comparison with patients treated with chemotherapy, NovoTTF treated patients achieved comparable median overall survival time, had fewer side effects, and improved quality of life scores reported.

Glioblastoma is the most aggressive and most common form of primary brain tumor in the United States. The disease affects about 10,000 Americans each year. The median overall survival time of first diagnosis is 15 months with optimal therapy, and median survival from the days of tumour 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.

"We're ahead today proud of the efforts and the performance of our team, grateful for our investors for their support and guidance, and humbled by the confidence of our patients and doctors," said Asaf Danziger, CEO of Novocure. "Our next task is to make available NovoTTF therapy as a treatment option for all recurrent GBM patients in the u.s."

"The FDA approval of the NovoTTF is the culmination of ten years of research, development and clinical trials carried out by an exceptional team of scientists, engineers and clinicians and built on the original insights of our founder and CTO Yoram PaltiM. d., Ph.d., "said William f. Doyle, the Executive Chairman Novocure."We look forward to this device recurrent GBM patients and their families, and we look forward to developing NovoTTF therapy for a number of extra solid tumor cancer. "

Crucial process results

The FDA approval was based on data from a central randomized trial of 237 patients with glioblastoma tumors who had recurred or progressed despite earlier surgery, radiation and chemotherapy treatments. Patients treated with NovoTTF only reached a comparable general survival time for patients treated with the doctor the choice of the best chemotherapy. The progression free survival at six months (PFS6) is 21% in the NovoTTF group compared to 15 percent in chemotherapy patients. Also dealt with the NovoTTF patients had a 14% tumour response (RR) compared to 10% in chemotherapy treated patients in the process, and three complete radiographic reactions were observed in the NovoTTF group compared with none in chemotherapy patients. NovoTTF treated patients reported improved quality of life scores and during the process, fewer side effects than patients treated with chemotherapy. Specifically, quality of life using the device was better than that of chemotherapy patients in the following domains subscale: vomiting, nausea, pain, diarrhea, constipation, cognitive function and emotional functioning, all of which are characteristics of patients suffering while receiving chemotherapy. The most frequently reported side effect of the NovoTTF treatment was a mild to moderate rash under the electrodes.

The NovoTTF-100

NovoTTF-100a is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device has been shown in in vitro studies and reverse slow down tumor growth by inhibiting mitosis, the process whereby cells divide and replicate. The NovoTTF-100a device, which weighs about six pounds (three kilograms), create a low-intensity, alternating electric field within the tumor that physical forces exerts on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to Division. Novocure currently has American and European marketing approvals for the NovoTTF-100a.

Ongoing clinical Studies

Novocure is sponsoring an ongoing crucial process of the NovoTTF for patients with tumors of the newly diagnosed glioblastoma under the application of an authorised medicinal device exemption (IDE).

Source: Novocure