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Fast-Track Designation for a Treatment for Ewing Sarcoma

doi: 10.1097/01.COT.0000489526.55774.94
FDA Updates
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The FDA has granted Fast-Track Designation for ets-family inhibitor TK216 in the treatment of patients with Ewing sarcoma who have relapsed or are refractory to standard of care therapy. Researchers are in the process of initiating a first-in-human phase I trial in relapsed or refractory Ewing sarcoma. More information can be found at ClinicalTrials.gov, including participating sites: Memorial Sloan Kettering Cancer Center in New York City, UCLA Jonsson Comprehensive Cancer Center in Los Angeles, and MD Anderson Cancer Center in Houston.

The FDA describes Fast Track as a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier by enabling more frequent communications with the agency to address potential questions and requirements, and to streamline regulatory submissions.

TK216 is a first-in-class small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins in a variety of tumor types, stopping cancer cell growth and tumor formation. In Ewing sarcoma, it is designed to target a single and well-characterized genetic mutation that causes the disease. TK216 is based upon the discoveries of Jeffrey A. Toretsky, MD at Georgetown University, who conducted extensive research on the ets-family of oncogenes that cause or drive tumor growth in a number of solid and hematologic malignancies. Researchers are also planning clinical studies in glioblastoma, prostate cancer, and lymphoma in the next year.

Wolters Kluwer Health, Inc. All rights reserved.
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