According to a press release from Business Wire, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recently issued a positive opinion in regards to the use of zanubrutinib (BRUKINSA) as a therapy for adult patients living with the rare cancer Waldenström’s macroglobulinemia (WM). The drug is being developed as a first-line treatment for patients not eligible for chemo-immunotherapy or as an option for patients that have been treated with one or more previous therapies.
About Waldenström’s Macroglobulinemia (WM)
Waldenström’s macroglobulinemia, which is also known as lymphoplasmacytic lymphoma, is a rare type of blood cancer that affects two types of B lymphocytes, including plasma cells and lymphoplasmacytoid cells. A distinct characteristic of this type of cancer is the presence of a high concentration of IgM antibodies. It is a slow-progressing form of blood cancer, and many patients can lead active lives. While it cannot be cured, it is treatable; some patients are able to experience years of remission without symptoms. There are only about 1,500 new cases per year in the U.S. Although it mostly occurs due to sporadic genetic mutations, a family history increases risk. Symptoms include vision loss, headaches, enlargement of the lymph nodes, liver, and spleen, bleeding nose and gums, weight loss, fatigue, and general weakness. To learn more about WM, click here.
Zanubrutinib is classified as a Bruton’s tyrosine kinase (BTK) inhibitor. This class of medicines has found success in the treatment of WM. The positive opinion from CHMP is based on findings from a phase 3 clinical trial. In this trial, zanubrutinib was compared side by side in WM with ibrutinib, another BTK inhibitor that has already been approved. Patients with refractory disease and patients that hadn’t received any treatment were included.
The primary endpoint in this study was the number of patients achieving complete response and very good partial response. A greater percentage of patients treated with zanubrutinib achieved complete response or very good partial response when compared to those treated with ibrutinib. The drug also had a better safety profile.
The European Commission will make a final decision on the marketing application for the drug 67 days after the CHMP opinion was issued. Zanubrutinib was recently approved in the US for WM and marginal zone lymphoma and had previously been approved to treat mantle zone lymphoma in the US as well.