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

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