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 lym 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 lym Hub cannot guarantee the accuracy of translated content. The lym 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.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by AbbVie, BeOne Medicines, Johnson & Johnson, Roche, and Sobi, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View lym content recommended for you
The FDA accepts a supplemental new drug application for zanubrutinib in Waldenström’s macroglobulinemia
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
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?