EMA Issues Positive Opinion on Zanubrutinib for Relapsed/Refractory MZL

The Committee for Medicinal Products for Human Use (CHMP) of the ​European Medicines Agency (EMA) has issued a positive opinion recommending approval of zanubrutinib for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

The CHMP recommendation is based on positive results from the phase II, open-label, multicenter, single-arm MAGNOLIA trial, which included 66 patients with relapsed or refractory MZL who received at least one anti-CD20-based regimen.

In the study, the overall response rate (ORR) was 68% (95% CI, 55.6-79.1), with 26% of patients achieving complete response and 42% achieving partial response. The median time to response was 2.8 months (range, 1.7-11.1 months); ORRs for extranodal, nodal, splenic, and unknown MZL subtypes were 64%, 76%, 67%, and 50%, respectively.

Following the CHMP positive opinion, the European Commission (EC) will consider the Marketing Application of the manufacturer of the drug, with a final decision expected within 67 days of the CHMP opinion. The decision will be applicable to all 27 member states of the European Union (EU) plus Iceland and Norway.

Source: Business Wire, September 2022