The FDA naive GBM Optune approval was on the interim data of 24 months but the trial continued for a full five years. The interim data was successful enough for DSMO to recommend the data analysis for FDA submission. But most of the patients crossed over to continue the trial which was published in JAMA and presented at ASCO. See press releases below:
From JAMA: "The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. These are the best results reported for newly diagnosed GBM patients in a phase 3 trial to date and represent a new landmark for five-year survival rate in this difficult to treat disease."
"Combination of Optune™ with Standard of Care Chemotherapy, Temozolomide, Provides Landmark Five-Year Survival Rates for Newly Diagnosed Glioblastoma Patients April 2, 2017 Final analyses provide unprecedented five-year survival advantage reinforcing Optune plus temozolomide as a combination treatment for glioblastoma patients Survival benefit was maintained in all patient subgroups, including those with the worst prognostic features
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today final results from its phase 3 pivotal EF-14 trial adding Optune to standard temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma (GBM). Landmark analyses show a consistent and maintained improvement in overall survival at two, three, four and five years. "
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