ST. HELIER, Jersey--(BUSINESS WIRE)--Physicians at more than 360 cancer treatment centers in the U.S. have been certified to prescribe Novocure’s (NASDAQ:NVCR) Optune to newly diagnosed and recurrent glioblastoma (GBM) patients. Physicians at an additional 140 medical institutions throughout the world also can prescribe Optune to GBM patients. Optune is a medical device used to deliver Tumor Treating Fields to disrupt cancer cell division and cause cancer cell death.
Physicians must be trained by Novocure to prescribe Optune therapy. Since FDA approval of Optune plus temozolomide for the treatment of newly diagnosed GBM in October 2015 based on the superior progression free and overall survival demonstrated in the EF-14 phase 3 pivotal clinical trial, physicians at more than 140 U.S. cancer treatment centers have been certified. An estimated 12,500 people are diagnosed with GBM or tumors that typically progress to GBM in the United States each year.
“More and more physicians are learning about Optune and the benefits it can offer GBM patients,” said Pritesh Shah, Novocure’s Senior Vice President, Americas. “We are committed to raising awareness of the therapy and making it readily available to the patients who need it.”
Recently certified centers include Ochsner Medical Center, Premier Health – Miami Valley Hospital/Dayton Physicians, Rocky Mountain Oncology Center, Tulane University Department of Neurosurgery, the University of Tennessee Medical Center Cancer Institute, and Vanderbilt-Ingram Cancer Center.
"Optune enables us to offer GBM patients a treatment option that can extend patients’ lives while maintaining their quality of life,” said Dr. Marcus L. Ware, Medical Director for Neurosurgical Oncology at Ochsner Medical Center.
About Novocure
Novocure is a commercial-stage oncology company developing a novel, 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.
Approved Indications
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, 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.
In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than four weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.
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.
