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September 16, 2021 – The U.S. FDA has approved two new indications for Brukinsa® (zanubrutinib), the first to treat adults who have Waldenström's macroglobulinemia (WM), and the second to treat adults who have relapsed or refractory marginal zone lymphoma (MZL) and have received at least one anti-CD20- based regimen.
- WM and MZL are slow-growing types of B-cell lymphoma. Although MZL is the second most common type of non-Hodgkin lymphoma, WM is rare.
- Brukinsa is also indicated to treat mantle cell lymphoma, another type of B-cell lymphoma.
- The recommended dosing is 160mg twice daily or 320mg once daily until disease progression or unacceptable toxicity occur. Brukinsa is an oral tablet that should be swallowed whole with water.
- Manufactured by BeiGene, Brukinsa first received FDA approval in 2019.