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FDA Approves Second-Generation Brain Cancer System
The FDA has cleared a premarket approval supplement application for the second-generation Optune system (Novocure). The smaller, lighter Tumor Treating Fields (TTFields) delivery system is now available to treat patients with glioblastoma in the United States.
The second-generation Optune system was designed to make treatment with TTFields more convenient and manageable for patients with glioblastoma multiforme (GBM). The new model features a TTFields generator that is less than half the weight and half the size of the generator in the first-generation Optune system. Including its battery, the second-generation Optune system weighs 2.7 pounds, compared with the first-generation system that weighs 6.0 pounds. Novocure started offering the second-generation Optune system to patients in Germany in October 2015.
The Optune system consists of two main components: an electric field generator (the Optune device) and insulated transducer arrays. In addition, the following components are included in the Optune treatment kit: power supply, portable battery, battery rack, battery charger, connection cable, and carrying case.
The Optune system produces alternating electrical fields within the human body that disrupt the rapid cell division exhibited by cancer cells, with the electrical fields applied to the brain through transducer arrays placed on the scalp.
TTFields harness electric fields to arrest the proliferation of tumor cells and destroy them, according to Novocure. The alternating electric TTFields alter the tumor-cell polarity at an intermediate frequency (100 to 300 kHz). The frequency used for a particular treatment is specific to the cell type being treated (e.g., 200 kHz for GBM).
Optune is intended as a treatment for adults (22 years of age or older) with histologically confirmed GBM. Optune with temozolomide (Temodar, Merck) is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma after maximal debulking surgery and the completion of radiation therapy together with concomitant standard-of-care chemotherapy.
In the U.S., the Optune system is indicated for the treatment of recurrent GBM following histologically or radiologically confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The system is intended to be used as monotherapy, and it is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.