Novocure announced that the US Food and Drug Administration (FDA) Neurological Devices Advisory Panel of the Medical Devices Advisory Committee voted (7 yes; 3 no; 2 abstain) that for patients with supra-tentorial Glioblastoma Multiforme (GBM) tumours that recur after maximal surgical and radiation treatments, there is reasonable assurance that the benefits of the NovoTTF-100A System (NovoTTF) outweigh its risks when administered as a monotherapy in place of standard medical therapy.
“We are pleased with the outcome of the Advisory Committee's vote on the safety and effectiveness of NovoTTF,” said Eilon Kirson, MD, PhD, and the Chief Medical Officer of Novocure.
The committee's recommendation followed a review of data from the EF-11 Trial, a randomized phase III trial for 237 patients with glioblastoma tumours that had recurred or progressed despite previous treatments. The committee received and considered the final data from the EF-11 Trial, which updated data previously reported at the American Society for Clinical Oncology Annual Meeting in June 2010.
The trial demonstrated that patients treated with the NovoTTF alone achieved a comparable overall survival time to patients treated with the physician's choice of the best chemotherapy. Patients treated with the NovoTTF also had higher rates of Progression Free survival at six months (PFS6) and higher tumour Response Rates (RR) compared to chemotherapy treated patients in the trial (PFS6 of 21 percent vs. 15 percent and RR of 14 percent vs. 10 percent).
NovoTTF treated patients reported better quality of life scores and fewer side effects during the trial compared to patients treated with chemotherapy. The NovoTTF's most commonly reported side effect was a mild-to-moderate rash beneath the electrodes.
“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 Novocure. The FDA is currently reviewing a Pre-Market Approval (PMA) application for the NovoTTF for this indication.
NovoTTF-100A is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. TTF therapy has been shown in vitro to slow and reverse tumour cell proliferation by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A device, which weighs about six pounds (three kilograms), creates a low-intensity, alternating electric field within the tumour that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division.
Novocure is now sponsoring a second phase III study of TTF therapy at 26 centres in the US, Europe, and Israel. This study is designed to enroll 283 patients with newly diagnosed glioblastoma tumours. It is a Jersey Isle based oncology company pioneering Tumour Treating Fields (TTF) therapy, a new modality for treating solid tumours.