FDA panel backs NovoCure's cancer treatment device
NovoCure Ltd announced that the US Food and Drug Administration (FDA) Neurological Devices Advisory Panel voted that its device for treating supra-tentorial glioblastoma multiforme (GBM) tumors is safe This is not formal approval for the device, which is used after surgery and radiation treatment, but the FDA tends to follow the recommendations of its panels.
The committee's recommendation followed a review of data from the EF-11 Trial, a randomized phase III trial 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. 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 and higher tumor response rates compared with chemotherapy treated patients in the trial.
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.
NovoCure CEO Asaf Danziger said, "We look forward to working with the FDA to bring this novel, important therapy to patients as soon as possible,"
The FDA is currently reviewing a pre-market approval (PMA) application for the NovoTTF for this indication.
NovoCure was founded in 2000 by Asaf Danziger and Prof. Yoram Palti and has raised $15 million to date from Pfizer, Johnson & Johnson and Index Ventures.
Mar 25, 2011