On january 19, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy (Press release, BeiGene, JAN 19, 2023, View Source [SID1234626350]).
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"BRUKINSA is a highly selective BTK inhibitor that has demonstrated clinically meaningful improvements over the first generation of BTK inhibitor in relapsed CLL," said Dr Renata Walewska, Department of Hematology, University Hospitals Dorset, Bournemouth, UK. "The authorization of BRUKINSA for MZL and CLL in Great Britain is a significant step forward for eligible patients and their physicians as there is no targeted treatment currently authorized for MZL patients other than chemoimmunotherapy, and it represents an alternative to current BTKi treatments for patients with CLL."
The MHRA authorization for CLL is based on two global Phase 3 clinical trials: SEQUOIA (NCT03336333)1, comparing BRUKINSA against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016)2, comparing BRUKINSA against IMBRUVICA (ibrutinib) in patients with relapsed/refractory (R/R) CLL.
The MHRA authorization for MZL is based on results from the multicenter, global, single-arm, open-label, Phase 2 MAGNOLIA3 trial in patients with R/R MZL who received at least one anti-CD-20 based regimen.
"As a BTK inhibitor designed to maximize BTK occupancy and minimize off-target binding, we believe BRUKINSA presents a very promising treatment option for eligible patients with MZL and CLL," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
"As we strive for delivering cancer medicines more quickly to more patients around the world, we are pleased with the progress we’ve made in bringing BRUKINSA to more eligible patients with hematological malignancies in Great Britain following these authorizations," added Dr. Robert Mulrooney, General Manager, UK & Ireland at BeiGene.
Earlier this year, the National Institute for Health and Care Excellence (NICE), recommended BRUKINSA for the treatment of Waldenström’s macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable. BRUKINSA has also been recommended by the Scottish Medicines Consortium for the treatment of adult patients with WM who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemoimmunotherapy.
BRUKINSA is currently authorized in the European Union, and Northern Ireland, as per rulings set out in the Northern Ireland Protocol,for the treatment of adult patients with WM who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemoimmunotherapy; for the treatment of adult patients with CLL and for adult patients with MZL who have received at least one prior anti-CD20-based therapy.
About Chronic Lymphocytic Leukemia
A life-threatening cancer of adults, CLL is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues4,5. CLL is the most common type of leukemia in adults, accounting for about one-quarter of new cases of leukemia6. In Europe, the estimated incidence is 4.92/100,000 persons per year7,8.
About Marginal Zone Lymphoma
MZL is a group of ultra-rare, slow growing B-cell malignancies that begin in the marginal zones of lymph tissue9. Epidemiological data from Europe is limited, but the incidence rate of MZL is estimated to range between 20 and 30 persons per million per year10,11,12. There are three different subtypes of MZL: extranodal marginal zone B-cell lymphoma, or mucosa-associated lymphoid tissue (MALT), which is most common; nodal marginal zone B-cell lymphoma which develops in the lymph nodes and is rare; and splenic marginal zone B-cell lymphoma which develops in the spleen, bone marrow, or both, and is the rarest form of the disease13.
About BRUKINSA
BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
BRUKINSA is supported by a broad clinical program which includes more than 4,700 subjects in 35 trials in more than 30 geographies. To date, BRUKINSA is approved in over 60 markets, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, Iceland, Norway and Switzerland.