Al's Comment:

 This is great news.  The NCCN basically sets the standard of care for cancer treatments. The NCCN treatments classification is:

NCCN Categories of Evidence and Consensus

  • Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
  • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
  • Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
  • Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.

Not only does this set the standard of care as including Optune, but it should make it impossible for insurance companies to deny it.


Posted on: 03/20/2018

 

NCCN Guidelines Recommend Optune in Combination with Temozolomide as a Category 1 Treatment for Newly Diagnosed Glioblastoma

Updated clinical practice guidelines indicate, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate

ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to recommend Optune® in combination with temozolomide as a category 1 treatment for newly diagnosed glioblastoma (GBM) in its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers.

NCCN panel members designated alternating electric field therapy, or Optune, as a Category 1 treatment recommendation for patients with newly diagnosed GBM in conjunction with temozolomide after maximal safe resection and completion of radiation therapy in patients with newly diagnosed GBM.

The updated recommendation follows the publication of Novocure’s EF-14 phase 3 pivotal trial five-year survival results in the Journal of the American Medical Association (JAMA) in December 2017. The EF-14 five-year survival results demonstrated Optune plus temozolomide significantly improved survival outcomes in patients with newly diagnosed GBM compared to temozolomide alone. A category 1 recommendation indicates, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

“Many physicians look to the NCCN Guidelines as the standard resource when determining the best course of treatment for patients,” said Asaf Danziger, Novocure’s Chief Executive Officer. “The introduction of Optune with temozolomide gives newly diagnosed GBM patients the potential for long-term survival. We believe the updated NCCN guidelines will increase physician awareness, particularly in the radiation oncology and medical oncology communities, helping us to reach patients earlier in the course of this aggressive disease.”

Optune has robust real-world evidence in GBM with more than 1,800 patients on therapy as of December 31, 2017 and more than 7,000 GBM patients treated to date. Physicians at more than 700 cancer centers in the U.S. – and at more than 1,100 medical institutions globally – have been certified to prescribe Optune to newly diagnosed and recurrent GBM patients.

About National Comprehensive Cancer Network

NCCN is a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians and other health care decision-makers.

About Novocure

Novocure is a global oncology company developing a proprietary platform technology called Tumor Treating Fields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.

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, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

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.

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.

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.

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 February 22, 2018, 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.

 

Source: Novocure

Media and Investor Contact:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com

 

 

 


Click HERE to return to brain tumor news headlines.


Our privacy / cookie policy has changed.
Click HERE to read it!