I sent a story about this in a recent news blast but this is the press release from Novocure and their take on the topic!
26 July 2016 NCCN Guidelines Recommend Optune as a Standard Treatment Option for Newly Diagnosed Glioblastoma |
Optune designated as category 2A treatment for newly diagnosed GBM, indicating uniform consensus that the intervention is appropriate ST. HELIER, Jersey – Novocure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has recommended Optune as a standard treatment option for newly diagnosed glioblastoma (GBM) in its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. NCCN panel members designated Optune together with temozolomide as a category 2A treatment for newly diagnosed GBM for patients with good performance status, indicating uniform consensus among panel members to add Optune to the guidelines for newly diagnosed GBM. Optune has been included in the NCCN Guidelines as a category 2B treatment option for recurrent GBM since 2015. The recommendation follows the publication of Novocure's EF-14 phase 3 pivotal trial data in The Journal of the American Medical Association (JAMA) in December, 2015. The EF-14 phase 3 pivotal trial demonstrated that adding TTFields to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival in newly diagnosed GBM. "The NCCN Guidelines aim to assist patients, their families and their medical teams in making informed treatment-related decisions with the goal of optimal cancer care," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "We believe the inclusion of Optune as a standard treatment option for newly diagnosed GBM serves as further validation of this noninvasive cancer therapy that has been shown to extend survival in newly diagnosed GBM." Physicians at more than 410 cancer centers in the U.S. – and at 600 medical institutions globally – have been certified to prescribe Optune to newly diagnosed and recurrent GBM patients. "Physicians look to the NCCN Guidelines as the standard resource when determining the best course of treatment for patients," said Pritesh Shah, Novocure's Senior Vice President, Americas. "Optune's inclusion as a recommended treatment for newly diagnosed GBM will help us to educate more physicians in the community setting, where newly diagnosed GBM patients are often treated. Increased physician awareness will help us to reach patients earlier in the course of this aggressive disease, which should translate to better outcomes." About National Comprehensive Cancer Network About Novocure Approved Indications 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. In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted. 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 Media and Investor Contact: |
Click here to unsubscribe or to change your subscriber options. This service is brought to you by http://www.investis.com |