ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ:NVCR) announced today 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). 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.
“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 Novocure
Novocure is a commercial-stage oncology company developing a proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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.
Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on March 1, 2016, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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