April 15, 2011 — The US Food and Drug Administration (FDA) has approved the NovoTTF-100A System (NovoTTF; Novocure) for the treatment of adults with glioblastoma multiforme (GBM) following tumor recurrence after chemotherapy.
NovoTTF consists of a thin helmet-like array of electrodes fixed to the scalp with tape and connected to a portable battery-powered device that delivers low-intensity alternating electric fields within the tumor. The fields prevent the normal mitotic process and cause cancer cell death before division. The most common adverse effect in clinical trials was a mild scalp rash that responded to cortisone cream.
In March 2010, the Neurological Devices Panel of the Medical Devices Advisory Committee voted 7 to 3 (with 2 abstentions) that, overall, the benefits of NovoTTF outweigh the risks in recurrent GBM.
The action was motivated by the relative safety of NovoTTF compared with the devastating adverse effects of GBM chemotherapy, and by the possibility that the device might offer a dramatically better quality of life (compared with chemotherapy) for patients with recurrent GBM. In such patients, life expectancy is measured in months rather than years. Median survival from the time of tumor recurrence is 3 to 4 months without additional effective treatment.
Pivotal Trial Results
The FDA approval was based on data from a randomized trial of 237 patients with glioblastoma tumors that had recurred or progressed despite previous surgery, radiation, and chemotherapy. In patients treated with NovoTTF alone, the overall survival time was similar to that in patients treated with chemotherapy.
The rate of progression-free survival at 6 months was 21% in the NovoTTF group compared with 15% in the chemotherapy group. Tumor response rates were 14% and 10%, respectively. Three complete radiographic responses were observed in the NovoTTF group compared with none in chemotherapy recipients.
As expected, patients using the NovoTTF device reported better quality-of-life scores and fewer side effects during the trial compared with patients who received chemotherapy.
"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective," Eilon Kirson, MD, PhD, Novocure's chief medical officer, said in a statement. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients and indirectly on their families."
Novocure currently has US and European marketing approvals for the NovoTTF-100A.
NovoTTF consists of a thin helmet-like array of electrodes fixed to the scalp with tape and connected to a portable battery-powered device that delivers low-intensity alternating electric fields within the tumor. The fields prevent the normal mitotic process and cause cancer cell death before division. The most common adverse effect in clinical trials was a mild scalp rash that responded to cortisone cream.
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| The NovoTTF-100A system |
The action was motivated by the relative safety of NovoTTF compared with the devastating adverse effects of GBM chemotherapy, and by the possibility that the device might offer a dramatically better quality of life (compared with chemotherapy) for patients with recurrent GBM. In such patients, life expectancy is measured in months rather than years. Median survival from the time of tumor recurrence is 3 to 4 months without additional effective treatment.
Pivotal Trial Results
The FDA approval was based on data from a randomized trial of 237 patients with glioblastoma tumors that had recurred or progressed despite previous surgery, radiation, and chemotherapy. In patients treated with NovoTTF alone, the overall survival time was similar to that in patients treated with chemotherapy.
The rate of progression-free survival at 6 months was 21% in the NovoTTF group compared with 15% in the chemotherapy group. Tumor response rates were 14% and 10%, respectively. Three complete radiographic responses were observed in the NovoTTF group compared with none in chemotherapy recipients.
As expected, patients using the NovoTTF device reported better quality-of-life scores and fewer side effects during the trial compared with patients who received chemotherapy.
"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective," Eilon Kirson, MD, PhD, Novocure's chief medical officer, said in a statement. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients and indirectly on their families."
Novocure currently has US and European marketing approvals for the NovoTTF-100A.
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