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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
Phase II MAGNOLIA trial: Efficacy and safety of zanubrutinib in marginal zone lymphoma
Bruton’s tyrosine kinase (BTK) inhibitors provide a highly selective mechanism of action in marginal zone lymphoma (MZL), targeting B-cell receptor signaling...
Zanubrutinib granted accelerated approval by the FDA for the treatment of patients with R/R MZL
On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with...
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