Glioblastoma Clinical Programs
Novocure developed the NovoTTF-100A SystemTM (NovoTTF-100A) to deliver TTF therapy for glioblastoma brain tumors. Glioblastoma is the most common form of primary brain cancer. The Central Brain Tumor Registry of the United States reports the annual incidence of glioblastoma at approximately 3.11 per 100,000 people, or approximately 9,500 people per year in the United States.
Recurrent Glioblastoma Tumors (see – www.novottftherapy.com)
The NovoTTF-100A has been evaluated in a pivotal (phase III) trial under an approved investigational device exemption (“IDE”) sponsored by Novocure. The trial studied patients with glioblastoma tumors that recurred after initial treatment. Patients in the trial were treated with either TTF therapy alone (monotherapy) or an effective chemotherapy agent selected by their oncologists. The results from this trial served as the basis for FDA's premarket approval of the NovoTTF-100A System. The NovoTTF-100A System was approved as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme, following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. The NovoTTF-100A has applied the CE Mark and is indicated as a treatment for recurrent glioblastoma in Europe.
Newly Diagnosed Glioblastoma Tumors
Novocure is currently sponsoring a pivotal (phase III) trial under an investigational device exemption (“IDE”) for patients with newly diagnosed glioblastoma tumors. Patients in the trial are randomized following surgery and radiation therapy to receive either NovoTTF in combination with temozolomide (Temodar; Merck & Co.) or temozolomide chemotherapy alone (currently the best standard of care for newly diagnosed GBM). The phase III trial is enrolling patients at sites throughout the US, Europe and Israel. Caution. The NovoTTF-100A in an investigational device for this clinical indication. Limited by United States law to investigational use. The safety and effectiveness of the NovoTTF-100A for newly diagnosed GBM has not been established.