On September 23, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage US-China oncology drug development company, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast-Track designation to Xynomic’s lead drug candidate abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory follicular lymphoma ("FL") (Press release, Xynomic Pharmaceuticals, SEP 23, 2019, View Source [SID1234539846]). Fast-Track is a designation by the FDA to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need.
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According to the U.S. National Cancer Institute, FL is the most common indolent non-Hodgkin’s lymphoma subtype in the U.S. with approximately 14,840 new cases per year. It often requires multiple lines of treatment. Despite current available therapies, the outlook for patients that fail third line FL treatment remains poor. The median PFS and EFS were both less than 1 year after third line of treatment. Xynomic is conducting a potentially pivotal Phase 2 trial of abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory FL in the U.S. and Europe.
FDA has already granted Fast-Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of renal cell carcinoma.