According to BeiGene, the drug’s manufacturer, the U.S. FDA has approved zanubrutinib (Brukinsa) capsules to treat adult patients with Waldenstrom macroglobulinemia (WM), a rare non-Hodgkin lymphoma. The FDA’s approval of BRUKINSA in WM is primarily based on efficacy results from the multicenter, open-label Phase 3 ASPEN trial (NCT03053440) comparing BRUKINSA to ibrutinib in patients with WM. A total of 201 patients with an MYD88 mutation (MYD88MUT) were enrolled in the randomized Cohort 1.

Source: BeiGene

Waldenstrom macroglobulinemia (WM) is an indolent (slow-growing) subtype of non-Hodgkin lymphoma that affects small lymphocytes (white blood cells). WM probably begins with one or more acquired changes (mutations) to the DNA of a single B lymphocyte. Cancer causes the overproduction of a monoclonal protein called “immunoglobulin M” (IgM), which can result in a thickening of the blood known as “hyperviscosity”. This monoclonal IgM protein may lead to many symptoms, including fatigue, unexplained weight loss, enlarged lymph nodes or spleen, weakness, and unexplained bleeding. At the time of diagnosis, WM most commonly involves the blood and bone marrow; however, WM can start almost anywhere and spread to nearly every part of the body, affecting the lymph nodes, liver, spleen, and stomach intestines or lungs. WM rarely involves the skin or thyroid gland.

• WM is rare, with an incidence rate of about 6 cases per million people per year in the United States. About 1,000 to 1,500 people are diagnosed with WM each year in the United States.

However, the current Waldenstrom macroglobulinemia (WM) treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (IMO-8400, APG2575, Perifosine, Zanubrutinib, Enzastaurin, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Waldenstrom macroglobulinemia (WM) treatment. The key companies in the advanced development stage are Eli Lilly and Company, Acerta Pharma BV, BeiGene, Celgene Corporation, etc., targeting WM.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Waldenstrom macroglobulinemia (WM) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making

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