Treovir announces today that G207 has been granted Fast Track Designation by the US FDA for treatment of recurrent high-grade gliomas in children.
Fast Track Designation will provide Treovir the benefit of more frequent meetings with the FDA to discuss G207’s development plan and ensure collection of appropriate data needed to support drug approval. Additionally, Treovir will benefit from more frequent written communication from FDA about such things as the design of proposed future clinical trials, the use of biomarkers, and potential eligibility for Accelerated Approval and Priority Review upon completion of pivotal trials.