Navigation Links
FDA approves the NovoTTF-100A system for the treatment of patients with recurrent glioblastoma multiforme (GBM) brain tumors
Date:4/15/2011

WASHINGTON, D.C. April 14, 2011 Novocure today announced that the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100A System (NovoTTF) for the treatment of adult patients with glioblastoma multiforme (GBM) brain tumors, following tumor recurrence after receiving chemotherapy. The portable, wearable device delivers an anti-mitotic, anti-cancer therapy as patients maintain their normal daily activities. The NovoTTF is a novel, first-in-class treatment option for patients and physicians battling glioblastoma.

"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective," said Eilon Kirson, M.D., Ph.D., Novocure's Chief Medical Officer. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients and indirectly on their families."

Results from a 237 patient randomized pivotal trial demonstrated that compared to patients treated with chemotherapy, NovoTTF treated patients achieved comparable median overall survival times, had fewer side effects, and reported improved quality of life scores.

Glioblastoma is the most aggressive and most common form of primary brain tumor in the United States. The disease affects approximately 10,000 Americans each year. The median overall survival time from initial diagnosis is 15 months with optimal therapy, and median survival from the time of tumor recurrence is only three to four months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.

"We move forward from today proud of the efforts and accomplishments of our team, thankful to our investors for their support and guidance, and humbled by the trust of our patients and physicians." said Asaf Danziger, CEO of Novocure. "Our next task is to make NovoTTF therapy available as a treatment option for all recurrent GBM patients in the US."

"The FDA approval of the NovoTTF device is the culmination of ten years of research, development and clinical trials conducted by an exceptional team of scientists, engineers, and clinicians and built on the original insights of our founder and CTO Yoram Palti, M.D., Ph.D." said William F. Doyle, Novocure's executive chairman. "We look forward to bringing this device to recurrent GBM patients and their families, and we look forward to developing NovoTTF therapy for a range of additional solid tumor cancers."

Pivotal Trial Results

The FDA approval was based on data from a randomized pivotal trial of 237 patients with glioblastoma tumors that had recurred or progressed despite previous surgical, radiation and chemotherapy treatments. Patients treated with the NovoTTF alone achieved a comparable overall survival time to patients treated with the physician's choice of the best chemotherapy. The rate of progression free survival at six months (PFS6) was 21% in the NovoTTF group compared to 15% in chemotherapy patients. Also, patients treated with the NovoTTF had a 14% tumor response rate (RR) compared to 10% in chemotherapy treated patients in the trial, and 3 complete radiographic responses were observed in the NovoTTF group compared to none in chemotherapy patients. NovoTTF treated patients reported better quality of life scores and fewer side effects during the trial compared to patients treated with chemotherapy. Specifically, quality of life using the device was better than that of chemotherapy patients in the following subscale domains: vomiting, nausea, pain, diarrhea, constipation, cognitive functioning and emotional functioning, all of which are hallmarks of patient suffering while receiving chemotherapy. The most commonly reported side effect from NovoTTF treatment was a mild-to-moderate rash beneath the electrodes.


'/>"/>

Contact: Frank Leonard
frank@novo-cure.com
917-656-3518
Edelman Public Relations
Source:Eurekalert

Related biology news :

1. FDA approves trial for type 1 diabetes treatment by Ben-Gurion U. and U. Colorado
2. DFG approves 12 new collaborative research centers
3. DFG approves funding for 17 new collaborative research centers
4. Death -- not just life -- important link in marine ecosystems
5. Stress wrecks intestinal bacteria, could keep immune system on idle
6. Common nanoparticles found to be highly toxic to Arctic ecosystem
7. A better understanding of the aging immune system
8. E. coli an unlikely contaminant of plant vascular systems
9. Human impacts on the marine ecosystems of Antarctica
10. A new signaling pathway of the immune system is elucidated
11. MIT systems biologists use computer models to predict animal cell behavior
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/22/2016)... , June 22, 2016   ... management and verification solutions, has partnered with ... software solutions for Visitor Management, Self-Service Kiosks ... provides products that add functional enhancements to ... provides corporations and venues with an automated ...
(Date:6/21/2016)... VANCOUVER, British Columbia , June 21, 2016 ... been appointed to the new role of principal ... has been named the director of customer development. ... , NuData,s chief technical officer. The moves reflect ... development teams in response to high customer demand ...
(Date:6/16/2016)... 2016 The global ... reach USD 1.83 billion by 2024, according to ... Technological proliferation and increasing demand in commercial buildings, ... drive the market growth.      (Logo: ... development of advanced multimodal techniques for biometric authentication ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... June 27, 2016 , ... Parallel 6 , ... announced today the Clinical Reach Virtual Patient Encounter CONSULT module which enables ... the physician and clinical trial team. , Using the CONSULT module, patients and physicians ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... for Amgen, will join the faculty of the University of North Carolina ... professor of strategy and entrepreneurship at UNC Kenan-Flagler, with a focus on the ...
(Date:6/27/2016)... --  Ginkgo Bioworks , a leading organism design ... awarded as one of the World Economic Forum,s ... innovative companies. Ginkgo Bioworks is engineering biology to ... in the nutrition, health and consumer goods sectors. ... including Fortune 500 companies to design microbes for ...
(Date:6/24/2016)... June 24, 2016 Epic Sciences unveiled ... cancers susceptible to PARP inhibitors by targeting homologous ... (CTCs). The new test has already been incorporated ... multiple cancer types. Over 230 clinical ... response pathways, including PARP, ATM, ATR, DNA-PK and ...
Breaking Biology Technology: