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

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.