Novocure Announces FDA Approval of the NovoTAL™ (Transducer Array Layout) System The NovoTAL System Enables Certified Physicians to Plan and Individualize NovoTTF™ Therapy for Recurrent Glioblastoma Patients
NEW YORK, Nov. 5, 2013 /PRNewswire/ -- Novocure announced today that the United States Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) System through a Premarket Approval (PMA) supplement. The NovoTAL System allows certified physicians to use the individual MRI data of recurrent glioblastoma multiforme (GBM) patients to optimize the field distribution and intensity of Tumor Treating Fields (TTFields) therapy.
"With the NovoTAL System, certified physicians generate individualized transducer array plans for their recurrent GBM patients. Physicians can now use clinical information and personalized patient characteristics in the transducer array planning process, which is essential for optimizing treatment with NovoTTF Therapy," said Dr. Eilon D. Kirson, Chief Science Officer and Head of Research and Development at Novocure. "Not only can physicians optimize transducer array placement at the start of NovoTTF treatment, but can adjust array placement as tumor characteristics change over time."
The NovoTAL System consists of a dedicated workstation and specialized, PMA supplement-approved software that enables physicians to determine optimal transducer array layouts based on morphological measurements of the head, tumor size and location, and the distribution of TTFields within the brain.
About the NovoTAL System
The NovoTAL System is a workstation-based propriety software tool that uses MRI head morphology, tumor size and location measurements, and tissue dielectric properties to optimize TTField distribution and intensity within the target tumor. The NovoTAL System has received FDA PMA supplement approval for use by physicians certified to prescribe the NovoTTF-100A System.
About the NovoTTF-100A System
NovoTTF-100A System is a portable, non-invasive medical device designed for continuous use throughout the day by patients. In vitro and in vivo studies have shown that that use of the NovoTTF-100A System slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A System weighs about six pounds (three kilograms) and creates a low intensity, alternating electric field within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death. In patients with recurrent glioblastoma brain tumors, the system has shown clinical efficacy comparable to that of active chemotherapies with better quality of life and without many of the side effects of chemotherapy. The NovoTTF-100A System has received marketing approval in the United States (U.S.) and is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.
The FDA has approved the NovoTTF-100A System for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed GBM, following histologically – or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The system is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in use of the system. Full prescribing information is available at www.novottftherapy.com or by calling toll free 1-855-281-9301.
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called NovoTTF Therapy. Novocure U.S. operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Peter Melnyk, Novocure