Zanubrutinib Approved for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

The FDA has approved zanubrutinib (Brukinsa®, BeiGene USA, Inc.) for treatment of chronic lymphocytic leukemia (CLL) and its tissue counterpart, small lymphocytic lymphoma (SLL). "Zanubrutinib is a next-generation, selective Bruton tyrosine kinase inhibitor with efficacy in relapsed CLL and SLL," wrote Constantine Tam, MD, the Director of Hematology at St. Vincent's Hospital in Melbourne, Australia, and colleagues, in their abstract of the SEQUOIA trial (NCT03336333), one of the studies on which...

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Zanubrutinib Approved for Mantle Cell Lymphoma

The FDA has approved zanubrutinib (Brukinsa®, BeiGene) for patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one previous therapy. The approval was based on two clinical trials. BGB-3111-206, a single-arm phase 2 trial, enrolled 86 patients with MCL whose disease progressed following at least one prior therapy. Patients received 160 mg of zanubrutinib orally twice daily until unacceptable toxicity or disease progression. The study's primary end point was ove...

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