Tocagen's Toca 511 & Toca FC drug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
Toca 511 & Toca FC, which treat patients with recurrent high grade glioma (HGG), are being evaluated in a clinical trial designed to serve as a potential registrational study.
“Receiving Breakthrough Therapy Designation from the FDA for recurrent HGG, the first time it has been granted for this type of brain cancer, highlights the urgent need for new treatment options for this deadly disease,” Tocagen CEO Marty Duvall said in a statement. “Based on the encouraging safety and efficacy data we have seen to date, advancing the development of Toca 511 & Toca FC continues to be our team’s top priority. We look forward to working closely with the FDA to expedite development and review of the product candidate and related activities.”
The FDA awards Breakthrough Therapy Designation to drugs that could potentially provide substantial improvement on one or more clinically significant endpoints over available therapy.
HGG, which are the most common and aggressive brain cancers, could affect 160,000 new patients worldwide in 2017 and 14,000 in the United States alone.
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