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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Ibrutinib/Rituximab FDA Approved: Treatment-Naive CLL/SLL

Today, the FDA expanded the approval of ibrutinib (Imbruvica®, Pharmacyclics LLC) to include combination therapy with rituximab for the first-line treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Ibrutinib, an oral Bruton's tyrosine kinase (BTK) inhibitor, has previously been approved for treatment-naive CLL in combination with obinutuzumab. The new approval was based on the Eastern Cooperative Oncology Group (ECOG) E1912 trial (NCT02048813), a mul...

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FDA Approves Acalabrutinib for CLL and SLL

The FDA has just granted supplemental approval to acalabrutinib (Calquence®, AstraZeneca) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The main difference between CLL and SLL is where they occur in the body; CLL most often originates in the blood and bone marrow, and SLL occurs primarily in the lymph nodes. However, both of these diseases are cancers of lymphocytes—a type of immune cell that helps the body fight infection. Indications of CLL or SLL in...

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FDA Approval: Venetoclax for CLL and SLL

The FDA has now approved venetoclax (Venclexta®, AbbVie Inc. and Genetech Inc.) for treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). "Patients never treated for their CLL have had to rely largely on chemotherapy as their initial treatment," said Michael Hallek, MD, lead investigator of the CLL14 study, Professor and Chairman at the Internal Medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany. "The a...

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Venetoclax for CLL/SLL With Matthew S. Davids, MD, MMSc

The FDA has recently expanded the label of venetoclax (Venclexta®, AbbVie Inc. and Genetech Inc.) to now include the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), including those requiring initial therapy. Venetoclax is a targeted therapy that binds to the BCL-2 protein, which stimulates apoptosis—programmed cell death—in cancer cells. Matthew S. Davids, MD, MMSc, Assistant Professor at Harvard Medical School, and colleagues conducted earlier re...

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