FDA Advisory Committee Recommends Brain Tumor System
A Food and Drug Administration (FDA) advisory panel met yesterday to review a novel device that blasts glioblastoma brain tumors with an electrical field. The meeting ended with the committee recommending approval of the NovoTTF-100A System (NovoTTF), noting the benefits outweigh any risks.
The NovoTTF was developed by NovoCure of Haifa, Israel and is approved in Europe.
Novocure announced shortly after the meeting, the 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) tumors 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.
Novocure is seeking approval to market the device for patients with GBM, the most common primary brain tumor diagnosed in adults. Median survival for GBM patients is just 10 months with fewer than 10% of survival five years after diagnosis.
Current treatment for GBM involves surgical resection, if possible, followed by radiation and chemotherapy. Approval of the NovoTTF by the FDA would give GBM patients another chance when the current treatments fail. The panel felt the device should only be an option for patients who have tried chemotherapy.
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 (PFS6) and higher tumor response rates (RR) compared to chemotherapy treated patients in the trial (PFS6 of 21% vs. 15% and RR 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.
The NovoTTF device is comprised of a four set of electrodes that are attached to a patient's shaved head, which are covered by what looks like a big white bandage. The device is powered by a 6 lb battery pack that is carried by the patient in an over-the-shoulder bag, allowing patients to maintain an active life while treating their cancer
Novocure is now sponsoring a second phase III study of TTF therapy at 26 centers in the US, Europe, and Israel. This study is designed to enroll 283 patients with newly diagnosed glioblastoma tumors. Patients will be randomized (2 to 1) to receive TTF therapy and temozolomide (Temodar; Merck & Co) or temozolomide alone (the current best standard of care).
The FDA is not required to follow the advice of its advisory committees, but it often does.