BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Patients with Marginal Zone Lymphoma
NICE recommendation marks first-ever treatment recommended for MZL and third NICE recommendation for BRUKINSA
London, UK,---August 1, 2024---BeiGene UK, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
“BRUKINSA is a highly selective BTK inhibitor that has been shown in clinical studies and real-world use to provide high response rates with durable disease control for eligible patients with MZL[i],” said Dr Renata Walewska, Department of Hematology, University Hospitals Dorset, Bournemouth, UK. “This decision is a significant step forward for patients in England and Wales, providing them access to a new and targeted treatment option for relapsed/refractory MZL.”
BRUKINSA is the first-ever treatment to be recommended by NICE for MZL.
“This decision is particularly important for MZL patients, whose only treatment options until now were chemotherapy and immunotherapy,” said Dallas Pounds, Director of Services at Lymphoma Action, “Providing access to an oral therapy is more convenient for many people and offers an additional treatment option for the significant number of patients who relapse.”
As stated in the FDG, NICE recommended BRUKINSA for use in MZL given that its cost-effectiveness estimates compared with the standard of care are within the acceptable range of use of NHS resources.
“We are delighted that NICE has recognized the clinical and economic benefit of BRUKINSA for eligible patients across three disease areas: chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia and now MZL,” said Dr. Robert Mulrooney, General Manager, U.K. & Ireland at BeiGene. “This recommendation is the latest example of our commitment to making innovative cancer medicines like BRUKINSA accessible and affordable for patients with hematological malignancies in the U.K.”
BRUKINSA is approved in more than 70 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea and Switzerland in selected indications, and is under development for additional indications globally. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.
About Marginal Zone Lymphoma
Marginal zone lymphoma (MZL) is a group of ultra-rare, slow growing B-cell malignancies that begin in the marginal zones of lymph tissue.[ii] Epidemiological data from Europe is limited, but the incidence rate of MZL is estimated to range between 20 and 30 persons per million per year.[iii],[iv],[v] 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 disease.[vi]
About BRUKINSA® (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease‑relevant tissues.
About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
