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Tablet formulation of zanubrutinib granted approval by the EC for all approved indications
On August 21, 2025, the European Commission approved a film-coated tablet formulation of zanubrutinib, a Bruton’s tyrosine kinase inhibitor, for all approved indications, including Waldenström macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.1,2
This approval follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.3 Zanubrutinib tablets (160 mg) were shown to be bioequivalent to zanubrutinib capsules in two single-dose, open-label, randomized phase I crossover studies in healthy individuals.3 On June 11, 2025, the U.S. Food and Drug Administration approved the tablet formulation of zanubrutinib for all U.S.-approved indications, including Waldenström macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, follicular lymphoma, and mantle cell lymphoma.4
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On average, how many patients with chronic lymphocytic leukemia do you see in a month?
