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Abexinostat granted FDA's Fast Track designation for the treatment of patients with relapsed or refractory follicular lymphoma

Sep 25, 2019

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On 23 July 2019, abexinostat was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use as a fourth-line monotherapy in patients with relapsed or refractory (R/R) follicular lymphoma (FL).1 Abexinostat is an oral small molecule inhibitor of histone deacetylase (HDAC) that alters the transcription of oncogenes and tumor suppressor genes, leading to inhibition of cancer growth. 

The Fast Track designation was based on the positive results from a multicenter phase II clinical trial FORERUNNER (NCT03600441), evaluating the efficacy and safety of abexinostat as a single agent in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The trial2 demonstrated an overall response rate (ORR) of 56% in patients with FL, 40% in T-cell lymphoma, and 31% in diffuse large B-cell lymphoma (DLBCL). Adverse events (grade ≥3) were reported in 88% of patients with NHL, with thrombocytopenia (80%), neutropenia (27%), and anemia (12%) the most frequently reported.

Abexinostat in combination with pazopanib was previously granted the FDA’s Fast Track designation as a first or second-line treatment for patients with renal cell carcinoma.

  1. Xynomic Pharmaceuticals Holdings, Inc. Xynomic Pharma receives Fast-Track designation from the US FDA for abexinostat as 4L therapy treating follicular lymphoma. Press release September 23 2019. [Accessed September 24 2019]
  2. Ribrag V, Kim WS, Bouabdallah R, et al. Safety and efficacy of abexinostat, a pan-histone deacetylase inhibitor, in non-Hodgkin lymphoma and chronic lymphocytic leukemia: results of a phase II study. Haematologica. 2017 May; 102(5):903-909. DOI: 10.3324/haematol.2016.154377

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