On September 19, 2016 Novocure (NASDAQ:NVCR) reported that CNS Oncology published Tumor Treating Fields (TTFields) treatment planning and patient follow-up guidelines, providing a standardized resource for the use of the NovoTAL System to optimize TTFields intensity in Optune patients with newly diagnosed and recurrent glioblastoma (GBM) (Press release, NovoCure, SEP 19, 2016, View Source [SID:SID1234515225]). Treatment planning with the NovoTAL System is an essential component of treatment with TTFields. The guidelines present a framework for utilizing the NovoTAL treatment planning software to start patients, monitor patient response and evaluate when TTFields treatment should be re-planned.
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"Transducer array placement and TTFields intensity are important factors in the success of treatment with Optune," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "We are pleased that CNS Oncology published treatment planning guidelines and believe the guidelines will advance Optune as a standard treatment option in GBM."
All glioblastoma patients starting Optune should receive treatment planning with the NovoTAL System. In simulation studies, personalized treatment planning with the NovoTAL system resulted in near doubling of TTFields intensity delivered to the tumor compared with TTFields delivered using a default symmetric array layout.
The guidelines explain that there may be a benefit to certified physicians conducting TTFields treatment planning because they have comprehensive information regarding the patients’ medical history, current medical status and knowledge of sequential imaging changes.
"The publication of TTFields treatment planning guidelines in CNS Oncology will increase physicians’ confidence when planning patients’ therapy with TTFields," said Dr. John Trusheim, lead author of the guidelines, Assistant Clinical Professor at the University of Minnesota Medical School and Medical Director of Neuro-oncology at the Virginia Piper Cancer Institute in Minneapolis. "This tool will help inform physicians on how to incorporate Optune into glioblastoma patients’ treatment, potentially resulting in better treatment outcomes."
Novocure’s EF-14 phase 3 pivotal trial data published in The Journal of the American Medical Association in December 2015 demonstrated that adding TTFields to maintenance temozolomide significantly extended progression free and overall survival in newly diagnosed GBM patients versus maintenance temozolomide alone.
About Glioblastoma Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. This means that GBM tumors begin in the brain, rather than traveling to the brain from other parts of the body, such as the lungs or breasts. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in adults than children and to affect men than women.
Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.