Gaithersburg, MD - On March 17, 2011, the Food and Drug Administration's Neurological Devices Panel endorsed the premarket approval application (PMA) for Novocure's NovoTTF-100A Treatment Kit - a novel, non-invasive device that blasts glioblastoma brain tumors with an electrical field.
The advisory panel voted 7-to-3 to recommend approval of NovoTTF, saying the benefits to GBM patients outweigh the risks. A favorable vote from an FDA panel typically results in the granting of a PMA to allow the device to be sold in the United States. However, the FDA can still rule against the device.
Brain cancer patients and advocates attended the panel hearing, including representatives from Accelerate Brain Cancer Cure, the Musella Foundation and the Chris Elliott Fund. Al Musella, founder of VirtualTrials.com, rallied a group of GBM patients to testify in support of the device. Scott Johnson was diagnosed with a GBM in 2009 and recounted how his chemotherapy treatments left him feeling exhausted and sick and unable to enjoy precious time with his family. Since using the NovoTTF, Johnson said, "it's allowed me to continue my life...when you don't feel good, it's hard to have hope." Cheryl Broyles, an active mother of two, said her tumor had come back three times and she has run out of treatment options, “As a GBM patient myself, I’m here because I want to stay alive.”
The NovoTTF system is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed recurrent GBM. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy.
The NovoTTF surrounds tumors with an intermediate-frequency electrical field that is thought to disrupt cell division, which, over time, may slow or even shrink the tumor.
The device is approved in Europe, but is still in late-stage clinical trials in the U.S. Trial sites include Baylor, MD Anderson-Orlando, USC, Swedish Neuroscience Institute and UNC.
NovoCure was founded in 2000 by Yoram Palti, a former researcher at the Technion-Israel Institute of Technology. NovoCure lists New York-based venture capital firm WFD Ventures as a primary investor.