A revolutionary treatment for a deadly form of brain cancer failed to show a significant increase in the overall survivability rate when measured against chemotherapy, according to an FDA reviewers document posted on the agency’s web site.
In reviewer materials released ahead of a March 17 meeting of the FDA’s neurological devices panel, Food & Drug Administration officials questioned claims made by NovoCure, a privately-held Israeli company, which is seeking pre-market approval for its NovoTTF-100A device.
The document said clinical trials of the device, described by the company as a “non-invasive device, consisting of four sets of insulated electrodes attached to an electronic box,” failed to show a significant increase in overall survivability rate when compared to the standard treatment of aggressive chemotherapy.
The one-year survival rate for patients using the NovoTTF devices versus chemotherapy was essentially the same, at 21.9 percent versus 22.1 percent using the FDA’s strict statistical measurements. Adjusted for the protocol set up in NovoCure’s clinical study, survival rate at one year was slightly higher at 27.8 percent, compared to 21.6 percent.
The biggest difference in the treatments came from quality-of-life scores in post-study patient surveys, which showed a significantly higher quality of life using the NovoCure device when compared to chemotherapy. In particular, patents reported significantly fewer instances of sever gastrointestinal distress including, nausea, vomiting, diarrhea, constipation and pain.
The NovoCure device did have a higher incident rate of convulsions, headaches and mental status changes, which the panel said it would ask company officials about during the March 17 review. However, the document did preface that convulsions are “expected in 20-50% of GBM subjects at various stages of their disease” and that the incidence of convulsions in this trial was low compared to other trials.
The FDA hasn’t made its final decision on the company’s PMA, but did ask questions about a post-market study of the device, stipulating that this shouldn’t be “interpreted to mean that FDA has made a decision on the approvability of this PMA device.”
The agency is considering the device as a treatment for glioblastoma “after surgical and radiation options have been exhausted,” according to a note in the Federal Register. Glioblastoma is the most common form of brain tumor and has a low survival rate.
Patients using the device, which resembles a cap of bandages with electrodes attached, are given continuous low-intensity, alternating electric fields directly to the tumor site. Patients undergoing the treatment are expected to continue wearing the device for more than 18 hours a day.
NovoCure was founded in 2000 by Yoram Palti, a former researcher at the Technion-Israel Institute of Technology. The company has been conducting a Phase III clinical trial of the device since June 2009. NovoCure counts New York-based venture capital firm WFD Ventures as a primary investor.