RARE Daily

BeiGene Receives U.K. Marketing Authorization for Brukinsa for the Treatment of Rare Cancers

January 19, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BeiGene’s Brukinsa in Great Britain for both the treatment of adult patients with the rare cancers chronic lymphocytic leukemia and marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

Chronic lymphocytic leukemia (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 tissues. CLL is the most common type of leukemia in adults, accounting for about one-quarter of new cases of leukemia.

Marginal zone lymphoma (MZL) is a group of ultra-rare, slow growing B-cell malignancies that begin in the marginal zones of lymph tissue. 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.

The MHRA authorization for CLL is based on two global phase 3 clinical trials comparing Brukinsa against bendamustine plus rituximab in patients with previously untreated CLL, and ALPINE 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, chief medical officer, Hematology 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 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.

To date, Brukinsa is approved in more than 60 markets, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, Iceland, Norway, and Switzerland.

Photo: Mehrdad Mobasher, chief medical officer, Hematology at BeiGene

Author: Rare Daily Staff

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