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.

2021-02-18T15:06:01.000Z

The FDA accepts a supplemental new drug application for zanubrutinib in Waldenström’s macroglobulinemia

Feb 18, 2021
Share:

Bookmark this article

On February 17, 2021, it was announced that the U.S Food and Drug Administration (FDA) accepted a supplemental new drug application for zanubrutinib, a small molecule Bruton’s tyrosine kinase inhibitor, for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). The decision was based on safety and efficacy data from 351 patients with WM across three trials: the phase III ASPEN study (NCT03053440), which compared zanubrutinib to ibrutinib for the treatment of WM; a phase II Chinese trial (NCT03332173) in relapsed/refractory (R/R) WM; and a phase I/II global trial (NCT02343120) in patients with B-cell malignancies. Safety data from 779 patients, across six clinical trials with zanubrutinib, were also included in the application.1

Zanubrutinib has previously received accelerated approval by the FDA for the treatment of patients with R/R mantle cell lymphoma. Zanubrutinib was also granted approval in China for R/R mantle cell lymphoma, as well as R/R chronic lymphocytic leukemia and small lymphocytic lymphoma. 1

  1. BeiGene announces U.S. FDA acceptance of supplemental new drug application for BRUKINSA (zanubrutinib) in Waldenström’s macroglobulinemia. https://ir.beigene.com/news-releases/news-release-details/beigene-announces-us-fda-acceptance-supplemental-new-drug. Published Feb 17, 2021. Accessed Feb 18, 2021.

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?
60 votes - 48 days left ...

Newsletter

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