A new treatment for a deadly form of brain cancer has been approved by the FDA and is cleared for sale in the U.S. market.
The NovoTTF-100A System (NovoTTF) made by NovoCure is a “non-invasive device consisting of four sets of insulated electrodes attached to an electronic box,” according to the privately-held Israeli company.
The FDA’s neurological devices panel last month voted 7-to-3, with 2 abstentions, that there is reasonable assurance that the benefits of the device outweigh its risks when “administered as a monotherapy in place of standard medical therapy” for treatment of for treating the brain cancer glioblastoma multiforme (GBM), according to a prepared release from the company.
Read all of our coverage on NovoCure’s revolutionary treatment for brain tumors
About 19,000 people in the United States are diagnosed with brain cancers every year, according to the National Cancer Institute. In 2010, more than 13,000 people died from brain and other nervous system cancers in the United States. GBM is the most common primary brain cancer and the tumor is highly resistant to standard treatments such as surgery, radiation and chemotherapy, according to the FDA.
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.
The company, which was founded in 2000 by Yoram Palti, counts New York-based venture capital firm WFD Ventures as a primary investor in the company. The company has been conducting a Phase III clinical trial of the device since June 2009. That trial is expected to be completed in October 2012.