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Zanubrutinib receives EC approval for the treatment of R/R marginal zone lymphoma
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On November 2, 2022, it was announced that the European Commission had granted approval to zanubrutinib, a Bruton’s tyrosine kinase inhibitor, for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior line of anti-CD20-based therapy.1
The approval follows a positive opinion granted by the European Medicine Agency’s Committee for Medicinal Products for Human Use in September of this year and is based on key results of the phase II MAGNOLIA trial (NCT03846427). In the trial, zanubrutinib demonstrated a high overall response rate and acceptable safety in marginal zone lymphoma, consistent with its established profile.
- Business Wire. BeiGene receives European Commission approval for BRUKINSA® (zanubrutinib) for the treatment of adults with marginal zone lymphoma. https://www.businesswire.com/news/home/20221102005244/en/BeiGene-Receives-European-Commission-Approval-for-BRUKINSA%C2%AE-zanubrutinib-for-the-Treatment-of-Adults-with-Marginal-Zone-Lymphoma. Published Nov 2, 2022. Accessed Nov 3, 2022.
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