The Food and Drug Administration has granted priority review designation to Tumor Treating Fields (TTFields) for use in combination with temozolomide chemotherapy as first-line treatment for patients with glioblastoma.
TTFields is a therapy delivered by a portable, non-invasive medical device designed for continuous use by patients that creates low-intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
The TTFields therapy-delivery system, also known as Optune (previously called the NovoTTF-100A System) has previously been approved for the treatment of adult patients over age 22 with histologically confirmed glioblastoma, following histologically or radiologically confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy (OT 5/10/11 issue).
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA).
A Phase III trial is currently ongoing in patients with newly diagnosed glioblastoma comparing treatment with TTFields plus temozolomide with temozolomide treatment alone. A pre-specified, interim analysis of the trial showed that two-year survival for the patients receiving TTFields with temozolomide was 48 percent higher than those receiving the chemotherapy alone; median progression-free survival for patients receiving the TTFields combination therapy was 7.1 months compared with four months for patients receiving chemotherapy alone; and patients receiving the TTFields combination had a median overall survival of 19.6 months compared with 16.6 months for patients receiving chemotherapy alone.