Removal of FDA contraindication increases addressable GBM patient population
ST. HELIER, Jersey–(BUSINESS WIRE)–A retrospective analysis of Novocure’s (NASDAQ: NVCR) Tumor Treating Fields (TTFields) therapy shows that TTFields therapy is safe in adult glioblastoma patients with implanted non-programmable shunts. The data were presented on Nov. 20 at the 20th Annual Society for Neuro-Oncology Meeting in San Antonio.
The analysis included 1,402 recurrent glioblastoma patients in the U.S. who were treated with TTFields therapy between November 2011 and May 2015. Among those patients, 49 had implanted medical devices: 44 patients had non-programmable shunts, two patients had programmable shunts and three patients had pacemakers/defibrillators. Shunts are implanted in the brain to resolve hydrocephalus, a condition characterized by a build-up of fluid within the ventricles of the brain that occurs in 2.5 percent to 10 percent of GBM patients. Safety data were analyzed to detect adverse events related to the implanted medical devices.
Adverse events reported by the 49 patients with implanted medical devices did not raise any new safety concerns regarding the use of TTFields therapy, and the analysis indicates that TTFields therapy is safe in patients with non-programmable shunts. Further investigation is needed to conclude whether TTFields therapy is safe in patients with programmable shunts and in patients with pacemakers/defibrillators.
After reviewing the safety data available from newly diagnosed GBM patients with shunts in Novocure’s EF-14 trial, the U.S. Food and Drug Administration removed a pre-existing contraindication in October 2015 stating that Optune should not be used in patients with non-programmable shunts.
“The removal of the contraindication from its regulatory labeling increases Optune’s addressable GBM patient population by approximately 5 percent,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Novocure strives to ensure the safety and efficacy of TTFields in all patients. This research supports that mission, while making our therapy available to a growing number of patients who suffer from this aggressive form of brain cancer.”
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 low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
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 supra-tentorial 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.
Novocure is a 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 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.
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Ashley Cordova, 212-767-7558