The FDA’s Neurological Devices Advisory Panel of the Medical Devices Advisory Committee voted 7 to 3 in favour of the benefits of the NovoTTF-100A System (Novocure) that outweigh its risks when administered as a monotherapy in place of standard medical therapy on patients with supra-tentorial glioblastoma multiforme tumours that recur after maximal surgical and radiation treatments. Two other members abstained from voting because of concerns that while trials showed safety of the device, it did not appear to be effective.
The committee’s recommendation followed a review of data from the EF-11 trial, a randomised phase III study for 237 patients with glioblastoma tumors 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.
“We are pleased with the outcome of the Advisory Committee’s vote on the safety and effectiveness of NovoTTF,” said Eilon Kirson, chief medical officer, Novocure.
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 compared to chemotherapy treated patients in the trial (PFS6 of 21% vs. 15% and response rates of 14% vs. 10%). 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, Novocure. The FDA is currently reviewing a pre-market approval application for the NovoTTF for this indication.
Novocure is now sponsoring a second phase III study of TTF therapy at 26 centres in the USA, Europe, and Israel. This study is designed to enroll 283 patients with newly diagnosed glioblastoma tumours.
About the NovoTTF-100A System
NovoTTF-100A is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. TTF (tumour treating fileds) therapy has been shown in vitro to slow and reverse tumor cell proliferation by inhibiting mitosis. The NovoTTF-100A device, which weighs about six pounds (three kilograms), creates a low-intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. The device has not been approved by the FDA for sale in the USA, however it is CE marked and is available to patients in Europe.