BRUKINSA (zanubrutinib) is a prescription medication which can be used to treat Waldenstrom macroglobulinemia (WM), mantle cell lymphoma, and marginal cell lymphoma. So far, the treatment has been approved in 44 different global markets. Most recently, biotechnology company BeiGene shared that BRUKINSA was approved by Swissmedic, the national medical supervisory agency, for the treatment of WM. In particular, this approval is for the treatment of adults who have not received treatment due to unsuitability or who have previously received at least one line of therapy.

About BRUKINSA (zanubrutinib)

The European Medicines Agency (EMA) describes how BRUKINSA works:

The active substance in Brukinsa, zanubrutinib, blocks the action of an enzyme known as Bruton’s tyrosine kinase (BTK). BTK is important for the growth of B cells, including the abnormal B cells in patients with Waldenström’s macroglobulinaemia.

Thus, BRUKINSA works by inhibiting BTK and slowing disease progression. The treatment is orally administered. It can be taken at either 160mg 2x daily or 320mg once daily. Learn more about BRUKINSA.

The approval in Switzerland hinged on data from the Phase 3 ASPEN study. During the study, researchers compared the effects of BRUKINSA as opposed to ibrutinib on individuals with WM who have a MYD88 gene mutation. Researchers found that:

• BRUKINSA had a higher partial response rate (29%) than ibrutinib (19%). It was also found to be relatively safer and better tolerated.
• Although BRUKINSA was relatively safe and well-tolerated, some adverse reactions did occur. These include diarrhea, neutropenia (low white blood cell count), subdural hemorrhage, and abnormal enlargement of the heart.

What is Waldenstrom Macroglobulinemia (WM)?

While doctors are not 100% sure what causes Waldenstrom macroglobulinemia (WM), a rare lymphoma, they do have some ideas. For example, an estimated 90% of WM cells are related to MYD88 gene mutations. Additionally, many people who have WM have “monoclonal gammopathy of unknown/undetermined significance” (MGUS) which eventually progresses to become WM. Regardless, WM forms in B lymphocytes, a type of white blood cell which normally helps the body fight infection. The WM cells then produce abnormal immunoglobulin M (IgM) and crowd out normal red blood cells. Ultimately, this causes thickened and hyperviscous blood.

WM is most common in Caucasians as opposed to other backgrounds. Additionally, this rare cancer is 2x more prevalent in males than females. Risk also increases with age. When symptoms appear, these include:

• Unintended weight loss
• Anemia (low red blood cell count)
• Easy bruising and bleeding
• Thrombocytopenia (low platelet counts)
• Neutropenia (low white blood cell counts)
• Fatigue and general malaise
• Enlarged lymph nodes (spleen)
• Weakness and breathlessness
• Abdominal distention
• Diarrhea
• Frequent infections
• Raised pink or flesh-colored skin lesions
• Dizziness and/or headaches
• Blurred vision and/or vision loss
• Nosebleeds