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Zanubrutinib receives positive CHMP opinion for the treatment of adult patients with MZL

Sep 20, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in marginal zone lymphoma.

On September 19, 2022, it was announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for the Bruton’s tyrosine kinase inhibitor zanubrutinib for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.1 This announcement is based on key data obtained from the phase II MAGNOLIA trial (NCT03846427).1

The MAGNOLIA trial reported an overall response rate of 68% (95% CI, 55.6–79.1), a complete response rate of 26%, and a partial response rate of 42%.1 The median time to response was 2.8 months. Extranodal, nodal, splenic, and unknown MZL subtypes demonstrated overall response rates of 64%, 76%, 67%, and 50%, respectively. In addition, zanubrutinib demonstrated an acceptable safety profile, consistent with previous studies.1

  1.  BeiGene receives positive CHMP opinion for BRUKINSA® (zanubrutinib) for the treatment of adults with marginal zone lymphoma. https://ir.beigene.com/news/beigene-receives-positive-chmp-opinion-for-brukinsa-zanubrutinib-for-the-treatment-of-adults-with-marginal/ff740209-b9b7-4600-b9a7-c2228f4a2328/. Published Sep 19, 2022. Accessed Sep 20, 2022.