- Advertisement -
- Advertisement -
- Advertisement -

Find a job

Subscribe for free

All things Pharma

EC grants marketing authorisation for marginal zone lymphoma treatment

The European Commission (EC) has granted marketing authorisation for BeiGene’s BRUKINSA® (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 EC granted an additional year of marketing protection because the data submitted for the therapeutic indication demonstrated a significant clinical benefit for BRUKINSA in comparison with existing therapies.

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, BRUKINSA 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. BRUKINSA also delivered rapid and durable disease control with a median time to response of 2.8 months.

Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene said: “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 hematological malignancy. This milestone builds on the track record we’ve built with BRUKINSA to date, with approvals in more than 55 countries and regions, as we continue to fulfill our commitment to build a transformational global R&D model that enables broader, faster access to novel medicines.”

Pier Luigi Zinzani, MD., PhD., Full Professor of Haematology at the Institute of Haematology “Seràgnoli”, University of Bologna, Italy said: “This milestone marks the first and only approved BTK inhibitor for marginal zone lymphoma in Europe. As there is no current standard of care in Europe, the approval of BRUKINSA 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.”

- Advertisement -
Emma Cooper
Emma Cooper
Emma is Content Manager at Pf Media.

MORE FROM AUTHOR

- Advertisement -

LATEST POSTS

Subscribe

Sign up to receive our digital newsletter, for all the essential headlines, Jobs of the Week and thought-provoking features.

Claim my free subscription