FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure announced today that it has received U.S. Food and Drug Administration (FDA) approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging (MRI) data of recurrent glioblastoma multiforme patients to optimize the field distribution and intensity of tumor treating fields (TTF) therapy.
NovoTAL System
The NovoTAL System is a workstation-based software tool that uses MRI head morphology, tumor size and location measurements, and tissue dielectric properties to optimize tumor treating field distribution and intensity within the brain tumor.
“With the NovoTAL System, certified physicians generate individualized transducer array plans for their recurrent glioblastoma multiforme 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 Eilon D. Kirson, MD, PhD, Chief Science Officer and Head of Research and Development at Novocure in a statement. "Not only can physicians optimize transducer array placement at the start of NovoTTF treatment, but they can adjust array placement as tumor characteristics change over time."
NovoTTF-100A System
In 2011, the FDA approved Novocure’s NovoTTF-100A System, a noninvasive medical device that produces a low-intensity, alternating electric field within a tumor, resulting in malignant cell death. The device is approved in the treatment of adult patients aged 22 and older with histologically confirmed glioblastoma multiforme, following confirmed recurrence in an upper region of the brain after receiving chemotherapy.
The system is intended for use as a monotherapy and as an alternative to standard medical therapy for glioblastoma multiforme after surgical and radiation options have been exhausted. 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 and is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.
Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in its use.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
