European Commission (EC) has granted marketing authorisation of zanubrutinib for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

The approval is applicable to all 27 member states of the European Union (EU), plus Iceland and Norway. 

Notably, the EC granted an additional year of marketing protection because the data submitted for the therapeutic indication demonstrated a significant clinical benefit for zanubrutinib in comparison with existing therapies.

“We are proud of what this approval means for European MZL patients, who previously did not have an approved BTK inhibitor as a treatment option for this rare haematological malignancy,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “This milestone builds on the track record we’ve built with zanubrutinib to date, with approvals in more than 55 countries and regions, as we continue to fulfil our commitment to building a transformational global R&D model that enables broader, faster access to novel medicines.”

The EC approval follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on results from the multicenter, global, single-arm, open-label, Phase 2 MAGNOLIA trial in patients with R/R MZL who received at least one anti-CD-20 based regimen.

In the trial, zanubrutinib achieved a high overall response rate of 68% with 26% of patients achieving complete remission, as assessed by an Independent Review Committee (IRC). Responses were observed in all patients regardless of MZL subtypes. Zanubrutinib also delivered rapid and durable disease control with a median time to response of 2.8 months.

Zanubrutinib was generally well-tolerated and safety in MZL was consistent with its established profile. The most common grade ≥3 adverse events (>5%) included neutropenia (23%), pneumonia (11%), thrombocytopenia (8%) and anaemia (8%). There were low rates of discontinuation due to adverse events at 3.5%, highlighting that zanubrutinib continued to be well-tolerated.ii

“This milestone marks the first and only approved BTK inhibitor for marginal zone lymphoma in Europe,” comments Pier Luigi Zinzani, MD., PhD., Full Professor of Haematology at the Institute of Haematology “Seràgnoli”, University of Bologna, Italy. “As there is no current standard of care in Europe, the approval of zanubrutinib provides a chemotherapy-free treatment option for people with MZL that has shown meaningful efficacy with durable and high response rates across MZL subtypes.”

Gerwin Winter, Senior Vice President, Head of Europe at BeiGene, notes, “We are excited to bring the first and only BTKi approved for MZL to patients in Europe and look forward to continuing to work with our growing and dedicated teams to make our medicine accessible to patients who need them across Europe.”

Zanubrutinib is also approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy, and last month, CHMP issued a positive opinion recommending approval of zanubrutinib for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).

Source: BeiGene