Posted on October 22nd, 2015 by
The United States Food and Drug Administration has expanded the approval of the Optune device for the treatment of patients with newly diagnosed glioblastoma multiforme.
Glioblastoma multiforme (GBM) is an extremely aggressive form of brain cancer. Average survival of patients with GBM is less than 15 months because the cancer tends to be resistant to standard therapies. Research is ongoing in order to identify treatment that provides lasting anti-cancer responses for patients with this disease.
Optune is a medical device that is already approved for patients with GBM whose disease recurs following prior therapy. The device is to be used in conjunction with treatment consisting of the chemotherapy agent, temozolomide (TMZ) and/or other standard therapies.
Optune is a device in which electrodes are placed on the surface of the patients scalp. These electrodes deliver low-intensity, alternating electrical fields referred to as “tumor treatment fields” (TTFields). The cancer cells, which have a unique shape and divide much more rapidly compared to healthy cells, are more susceptible to damage to TTFields. In turn, the damaged cancer cells stop growing.
Optune is a portable device that can be powered with batteries or plugged into an electrical circuit, allowing patients to continue their normal activities.
The trial prompting approval of Optune for newly diagnosed GBM included 695 patients who had not received prior therapy for their disease. One group of patients received standard therapy with the chemotherapy agent temozolomide, while the other group of patients received treatment with temozolomide plus Optune.
The average survival was 19.4 months for patients treated with Optune plus temozolomide, compared with only 16.6 months for patients treated with temozolomide only.
Average survival with no disease progression was 7 months for patients who received treatment with Optune/temozolomide, compared with only 4 months for patients who received temozlomide only.
The most common side effect associated with Optune was skin irritation.
William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health stated that “while the treatment is not a cure, it can increase survival by several months.”
Reference: United States Food and Drug Administration. FDA News Release. FDA approves expanded indication for medical device to treat a form of brain cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465744.htm. Accessed October 12, 2015.
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