Wednesday, October 7, 2015

FDA APPROVES OPTUNE IN COMBINATION WITH TEMOZOLOMIDE FOR THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA

Optune is the first FDA-approved therapy in more than a decade to demonstrate statistically significant extension of survival in newly diagnosed glioblastoma patients

The EF-14 trial achieved statistically significant extension of both progression-free survival and overall survival in newly diagnosed glioblastoma with a 50% increase in the number of patients alive two-years after starting treatment when treated with TTFields in combination with temozolomide as compared to temozolomide alone

ST. HELIER, Jersey, Oct 6 (Bernama-BUSINESS WIRE) -- Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) has approved Optune in combination with temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM). Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields – referred to as Tumor Treating Fields (TTFields) – that inhibit cancer cell replication and cause cancer cell death.


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