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FDA grants breakthrough therapy designation to zanubrutinib for mantle cell lymphoma
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The FDA granted breakthrough therapy designation to zanubrutinib for the treatment of adults with mantle cell lymphoma who received at least one prior therapy.
Zanubrutinib (BGB-3111, BeiGene) is an investigational Bruton’s tyrosine kinase inhibitor under investigation as monotherapy or as part of combination treatment for B-cell malignancies.
“We are very excited to receive the breakthrough therapy designation from the FDA,” Jane Huang, MD, chief medical officer for hematology at BeiGene, said in a company-issued press release. “Zanubrutinib has been designed to maximize BTK occupancy and minimize off-target effects. We believe that the breakthrough therapy designation underscores the potential of zanubrutinib as a meaningful treatment for patients with mantle cell lymphoma who have received at least one prior therapy.”
BeiGene’s clinical program includes seven phase 3 or pivotal trials of zanubrutinib. The trials have included patients with mantle cell lymphoma, Waldenström’s macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, and follicular lymphoma.
The FDA previously granted fast track designation to zanubrutinib for treatment of Waldenström’s macroglobulinemia.