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.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your Lymphoma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.

The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC. View funders.

2019-09-25T08:57:05.000Z

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

Sep 25, 2019
Share:

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.

  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. https://www.globenewswire.com/news-release/2019/09/23/1918959/0/en/Xynomic-Pharma-Receives-Fast-Track-Designation-from-the-US-FDA-for-Abexinostat-as-4L-Therapy-Treating-Follicular-Lymphoma.html. [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

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

  Thank you

Your opinion matters

HCPs, what is your preferred format for educational content on the Lymphoma Hub?
27 votes - 2 days left ...

Newsletter

Subscribe to get the best content related to lymphoma & CLL delivered to your inbox