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FDA Expands Optune's Glioblastoma Multiforme Indication

William Maisel, MD

William Maisel, MD, MPH

The FDA has approved Optune (formally the NovoTTF-100A System) in combination with adjuvant temozolomide as a treatment for patients with newly diagnosed glioblastoma multiforme (GBM) following surgery, chemotherapy, and radiation therapy, based on an improvement in survival in the EF-14 trial.

In an analysis of 695 patients enrolled in the phase III EF-14 study, the median overall survival (OS) was 19.4 months with Optune compared with 16.6 months with temozolomide alone. Additionally, progression-free survival (PFS) was improved by approximately 3 months, according to the FDA. Click here to read the full article at

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