This article is more than 5 years old. Information may no longer be current.

FDA panel: Benefits outweigh risks of non-invasive therapy for glioblastoma

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA Neurological Devices Advisory Panel of the Medical Devices Advisory Committee voted 7 to 3 in favor of the NovoTTF-100A System for patients with supra-tentorial glioblastoma multiforme tumors that recur after maximal surgical and radiation treatments. According to the panel, there is reasonable evidence demonstrating that the benefits of the system as monotherapy outweigh the risks associated with standard medical therapy.

The FDA is currently reviewing a pre-market approval application for the NovoTTF for this indication.

NovoTTF-100A, manufactured by NovoCure, is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. In vitro, Tumor Treating Fields (TTF) therapy inhibits mytosis, thereby slowing and reversing tumor cell proliferation. The device weighs about 6 lb and creates a low-intensity, alternating electric field within the tumor that applies physical forces on electrically charged cellular components to prevent mytosis, according to a press release. Currently in the US, the device is investigational and has not been approved by the FDA for sale for any use. Novocure currently has CE mark for the NovoTTF-100A and the treatment is available to patients in Europe, according to the release.

The committee’s recommendation was based on data from the EF-11 trial, a randomized phase 3 trial of 237 patients with glioblastoma tumors that had recurred or progressed despite previous treatments. The committee reviewed the final data from the EF-11 trial, which updated data previously reported at the ASCO Annual Meeting in June 2010.

The trial demonstrated that OS was similar between patients treated with TTF alone and those treated with the physician’s choice of the best chemotherapy. Patients treated with TTF also had higher rates of PFS at 6 months and higher tumor response rates (RR) compared with patients treated with chemotherapy (PFS = 21% vs. 15%; RR = 14% vs. 10%). Patients treated with TTF reported superior quality of life scores and fewer side effects compared with patients treated with chemotherapy. The most commonly reported side effect in the TTF arm was a mild-to-moderate rash beneath the electrodes.

A second phase 3 study of TTF therapy, designed to enroll 238 patients with newly diagnosed glioblastomas is currently being developed. The trial will be conducted at 26 centers in the US, Europe, and Israel. Patients will be randomly assigned (2 to 1) to receive TTF therapy and temozolomide (Temodar; Merck and Co.) or temozolomide alone, the current standard of care.

Follow HemOncToday.com on Twitter.