All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
Bookmark this article
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.
Understanding your specialty helps us to deliver the most relevant and engaging content.
Please spare a moment to share yours.
Please select or type your specialty
Your opinion matters
Ibrutinib and nivolumab combination in R/R NHL and CLL/SLL patients
In this two-part, phase 1-2a study the appropriate dose (phase 1) and the safety and activity (phase 2a) of ibrutinib in combination with nivolumab were asssesed in R/R NHL or...
Phase II trial results of abexinostat in R/R NHL and CLL
In January 2017, Vincent Ribrag from the Institut de Cancérologie Gustave Roussy, Paris, and colleagues published in Haematologica the results of a phase II study of abexinostat in the...
Subscribe to get the best content related to lymphoma & CLL delivered to your inbox