FDA approved NovoTTF-100a-system for the treatment of patients with recurrent brain tumors, glioblastoma Multiforme (GBM)

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NovoCure announced that the U.S. food and Drug Administration (FDA) the NovoTTF-100a system (approved NovoTTF) for the treatment of adult patients with glioblastoma Multiforme (GBM) brain tumor to tumor recurrence following chemotherapy. The portable, portable device offers anti-mitotic, cancer treatment when patients maintain their normal daily activities. The NovoTTF is a novel, first-in-class treatment option for patients and doctors fight glioblastoma.

"Our device offers patients and physicians with novel, non-invasive alternative to chemotherapy, which is safe and effective,", Novocure's chief medical officer said Eilon B.med.SC, m.d., PhD.. "The device allows a continuous treatment without the usual, debilitating side effects that cause chemotherapy on patients with recurrent GBM respond indirectly to their families."

Results a 237 randomized pivotal study with patients demonstrated that compared to patients with chemotherapy, NovoTTF treated were treated patients comparable median overall survival times had less side effects and improved quality of life scores reported.

Glioblastoma Multiforme 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 overall median survival of first diagnosis is 15 months with optimal treatment, and median survival from the time of the 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.

"We of today proudly on the efforts and successes of our team, to promote thankful to 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 the NovoTTF therapy as a treatment option for all recurrent GBM patients in the United States available"

"The FDA approved of NovoTTF device is the culmination of ten years of research, development and clinical trials under the direction of an exceptional team of scientists, engineers and clinicians and the original insights of our founder and CTO Yoram Palti gebautM.d., PhD.", "Said William F. Doyle, Novocure's executive Chairman.""We look forward to this device with recurrent GBM patients and their families to bring, and we look to develop us NovoTTF treatment for a number of additional solid tumor cancers."

Pivotal trial results

The FDA approval is based on data from a randomized trial of 237 patients with glioblastoma tumors, which repeated or advanced despite previous treatments for surgical, radiation and chemotherapy. Patients treated with the NovoTTF alone a comparable achieved survival choice of the best chemotherapy as a whole with the doctor treated patients. The progression-free survival after six months (PFS6) was 21 percent in the NovoTTF group compared to 15% in chemotherapy patients. A 14 percent tumor-response rate (RR) compared to 10 percent in chemotherapy patients treated with the NovoTTF had treated patients in the study, and three full radiological responses in the NovoTTF group compared to none in chemotherapy patients were observed. NovoTTF treated patients results and fewer side-effects reported better quality of life during the process when compared to patients with chemotherapy treated. In particular the quality of life with the device was better than that of the chemotherapy patients in the following areas of subscale: vomiting, nausea, pain, diarrhea, constipation, cognitive function and emotional work, suffer all the hallmarks of the patients are at the same time receiving chemotherapy. The most reported side-effect of NovoTTF treatment was mild to moderate rash below the electrodes.

The NovoTTF-100a

NovoTTF-100a is a portable, non-invasive medical device for continuous operation in the course of the day by the patient. The device was in in-vitro studies to slow and reverse tumor growth by inhibiting mitosis, the process by the divide and replicate cells shown. The NovoTTF-100a device, which weighs about six pounds (three kilograms), created a low intensity, alternating electric field within the tumour, which physical forces on electrically charged has cellular components, cell death prevents the normal mitotic process and cancer before the Division. NovoCure has currently us and European marketing approval for the NovoTTF-100a.

Ongoing clinical trials

NovoCure sponsorship is a current pivotal from the NovoTTF patients with newly diagnosed glioblastoma tumors under an approved investigational device exemption (IDE) application.

Source: Novocure