This is a good first step but way too little. The NCCN guidelines should have made it a standard treatment for both newly diagnosed as well as recurrent glioblastoma. The upgrade from Category 3 to Category 2B will help with insurance coverage issues, but again, they are too conservative and should have upgraded it to a Category 1, which should eliminate all insurance issues and allow access to everyone who needs Optune.. Hopefully when the results of the recent phase 3 trial for newly diagnosed GBM patients is published, they will revise the guidelines again and give it a Category 1 for both newly diagnosed as well as recurrent GBM.
Novocure a commercial stage oncology company announced today that Optune has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. The updated NCCN Guidelines indicate that physicians should consider alternating electric field therapy or Tumor Treating Fields (TTFields) for patients with glioblastoma (GBM) brain tumors that recur or progress after initial treatment. Optune has been upgraded from a Category 3 to a Category 2B treatment reflecting that there is NCCN consensus that the intervention is appropriate.
Optune is a portable non-invasive anti-mitotic device that delivers TTFields. In patients with recurrent GBM Optune demonstrated efficacy outcomes comparable to physician’s choice of chemotherapy including bevacizumab with significantly fewer of the systemic side effects associated with chemotherapy. There are more than 185 leading cancer centers in the US that offer Optune for the treatment of recurrent GBM.
“The revised NCCN guidelines reflect the growing use of Optune by oncologists to treat patients with recurrent GBM” said Pritesh Shah US General Manager at Novocure. “With the expanding body of clinical evidence and as more physicians gain practical experience with Optune we believe that TTFields therapy will become a standard-of-care for recurrent GBM.”
About National Comprehensive Cancer Network
NCCN is a not-for-profit alliance of 26 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 Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis the process by which cells divide and replicate. TTFields therapy creates a low intensity alternating electric field within a tumor that exerts physical forces on electrically charged cellular components preventing the normal mitotic process and causing cancer cell death.
The US FDA has approved the TTFields therapy delivery system Optune (previously known as the NovoTTF-100A System) for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed GBM following histologically or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as 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.
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth NH and New York NY. Additionally the company has offices in 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.