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FDA grants priority review of zanubrutinib for R/R MCL

Aug 22, 2019
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On the 21st of August, the US Food and Drug Administration (FDA) accepted a new drug application (NDA) for zanubrutinib (BGB-3111) for the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and granted a Priority Review designation. Zanubrutinib had previously received Breakthrough Therapy designation by the FDA at the beginning of this year.

Zanubrutinib is an inhibitor of Bruton’s tyrosine kinase (BTK), involved in pathways regulating B-cell proliferation, chemotaxis, and adhesion. The NDA was based on positive data from preclinical studies, a Phase 1/2 trial (NCT02343120) in patients with B-cell lymphomas, and a Phase 2 trial of zanubrutinib in patients with R/R MCL (NCT03206970), as well as safety data from other clinical studies.

Clinical trials of zanubrutinib as a single agent are ongoing in patients with Waldenström macroglobulinemia (WM), untreated MCL, and R/R marginal zone lymphoma (MZL). There are also studies investigating the combination of zanubrutinib and obinutuzumab for treatment-naive and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and R/R follicular lymphoma.

  1. BeiGene. BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma. Press release. 21 August 2019. http://ir.beigene.com/news-releases/news-release-details/beigene-announces-us-fda-acceptance-and-grant-priority-review.  [Accessed: 21 August 2019]