A new treatment for a deadly form of brain cancer has received a favorable vote from an FDA panel, moving the device a step closer to the market.
The FDA’s neurological devices panel voted 7-to-3 with 2 abstains that there is reasonable assurance that the benefits of the NovoTTF-100A System (NovoTTF) made by NovoCure, outweigh its risks when, “administered as a monotherapy in place of standard medical therapy,” according to a prepared release from the company.
The NovoTFF is a “non-invasive device, consisting of four sets of insulated electrodes attached to an electronic box,” according to the privately-held Israeli company.
A favorable vote from an FDA panel typically results in the granting of premarket approval or a PMA to allow the device to be sold in the United States. However, the agency can still rule against the device.
The Food and Drug Administration is considering the device as a treatment for glioblastoma “after surgical and radiation options have been exhausted.” Glioblastoma is the most common form of brain tumor and has a low survival rate.
“We are pleased with the outcome of the Advisory Committee’s vote on the safety and effectiveness of NovoTTF,” said Eilon Kirson, Novocure’s chief medical officer.
On March 16 an FDA reviewers document posted on the agency’s web site said that clinical trials of the devices failed to show a significant increase in the overall survivability rate when measured against chemotherapy, but did significantly improve quality of life when compared to aggressive forms of chemotherapy.