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Zanubrutinib granted priority review by the FDA for the treatment of adult patients with R/R MZL
By Claire Baker
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On May 19, 2021, the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application for zanubrutinib for the treatment of adult patients with relapsed or refractory marginal zone lymphoma. The application for the Bruton’s tyrosine kinase inhibitor also received priority review. Treatment criteria indicate that patients must have received previous treatment with ≥1 CD20-directed therapy.
The application was based on clinical data from the phase II MAGNOLIA trial, which you can read more about here. A decision on the status of the application is due by September 2019.
Zanubrutinib previously received approval by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
- BeiGene. BeiGene announces U.S. FDA acceptance and priority review of supplemental new drug application for BRUKINSA® (zanubrutinib) in marginal zone lymphoma. https://beigeneltd.gcs-web.com/news-releases/news-release-details/beigene-announces-us-fda-acceptance-and-priority-review?loc=us. Published May 19, 2021. Accessed May 19, 2021.
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