"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|
Edelman Public Relations