BeiGene’s Brukinsa (zanubrutinib) has been approved by the European Commission (EC) 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 company announced.
The EC also 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,’ BeiGene said in a statement.
The approval, which is applicable to all 27 member states of the EU, plus Iceland and Norway, follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
This was based on results from the phase 2 MAGNOLIA trial in which Brukinsa, a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), achieved a high overall response rate of 68%, with 26% of R/R MZL patients achieving complete remission. The treatment also delivered ‘rapid and durable’ disease control with a median time to response of 2.8 months.
In terms of safety, Brukinsa was generally well-tolerated and safety in MZL was consistent with its established profile, the company reported.
MZL is a group of ultra-rare, slow growing B-cell malignancies that begin in the marginal zones of lymph tissue. Epidemiological data from Europe is limited, BeiGene said, but the incidence rate of MZL is estimated to range between 20 and 30 people per million per year.
Commenting on the significance of the approval, Pier Luigi Zinzani, full professor of haematology at the Institute of Haematology, University of Bologna, 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.”
Brukinsa is also approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or as a first-line treatment of patients unsuitable for chemo-immunotherapy. Additionally, the CHMP issued a positive opinion recommending approval of Brukinsa for the treatment of adult patients with chronic lymphocytic leukaemia last month.