This past week, the US Food and Drug Administration announced the approval of the NovoTTF-100A System (pictured) designed to treat adults with aggressive brain tumors that recur after treatment.
Every year, according to the National Cancer Institute, about 19,000 people a year are diagnosed with primary brain cancers. Overall survival time from initial diagnosis is 15 months with therapy. Standard treatment is 6 weeks of high-dose radiation along with a chemotherapy pill, and then additional chemotherapy until the tumor stops responding.
With this new system, made by Novocure, 4 electrodes are placed on the surface of the patient’s shaved scalp to deliver low-intensity, electrical fields called tumor treatment fields (TTFs) to the tumor site.
Tumor cells that are dividing and multiplying have unique shapes and electrical characteristics. These make them susceptible to damage when exposed to TTF, which then stops the tumor’s growth.
The approval was based on a clinical study with 237 patients with glioblastoma tumors that have recurred or progressed despite surgery, radiation, or chemotherapy.
- The survival rates were comparable between those treated with NovoTTF and the control patients who underwent chemotherapy.
- Patients in both groups lived just over 6 months. According to Novocure, the rate of progression-free survival at 6 months was 21% in the NovoTTF group, compared to 15% in chemotherapy patients.
- While patients trying the new device experienced slightly more convulsions and headaches, they didn’t experience many significant side effects associated with chemotherapy, including nausea, anemia, fatigue, diarrhea, constipation, and serious infections.
A panel of FDA advisers narrowly voted 7-6 in favor of the effectiveness of the device last month, AP reports.
Novocure is sponsoring an ongoing trial of the NovoTTF for patients with newly diagnosed glioblastoma tumors.