An FDA panel voted 7 to 3 (2 abstentions) in support of the NovoTTF-100A System
An FDA panel voted 7 to 3 (2 abstentions) in support of the NovoTTF-100A System (NovoTTF), an experimental device that uses electric fields to treat glioblastoma after the failure of initial treatment. The committee evaluated NovoTTF’s clinical trial results, and a majority decided the treatment’s potential benefits outweigh its risks. The dissenters agreed that the product is safe, but were not convinced of its efficacy. The FDA will now consider the panel’s recommendation and make a final decision.
NovoTTF disrupts brain cancer cell growth by delivering a low-intensity, alternating electric field through the scalp to the tumor site. The noninvasive device consists of insulated electrodes that connect to a box that generates the electric field. NovoTTF weighs 6 pounds and comes with a carrying case, making it easily portable. Patients self-administer the treatment throughout the day.
"We look forward to working with the FDA to bring this novel, important therapy to patients as soon as possible," said Asaf Danziger, CEO of manufacturer NovoCure, in a press release.
The data reviewed by the FDA panel came from the phase III randomized EF-11 Trial, which accrued 237 patients with glioblastoma who had tumor progression or recurrence after standard treatment. According to NovoCure, progression-free survival rates at 6 months for patients randomized to NovoTTF compared with the standard chemotherapy cohort were 21% versus 15%, respectively. Tumor response rates for the NovoTTF group were 14% versus 10% in the placebo cohort. NovoTTF’s most common side effect is the development of a rash where the treatment is applied.
According to the National Cancer Institute (NCI), glioblastoma, or glioblastoma multiforme, accounts for 12% to 15% of all adult brain cancers. Standard treatment options for the aggressive brain tumor include surgery, radiation, and chemotherapy. Survival rates with standard treatment are low, and the NCI views the glioblastoma population as ideal candidates for clinical trials that supplement standard treatment with novel therapies.