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Outline
What is the generic name?
ZANUBRUTINIB
What is the Trade Name for ZANUBRUTINIB?
BRUKINSA
What are the Indications for ZANUBRUTINIB?
- 1 INDICATIONS AND USAGE BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenstr√∂m’s macroglobulinemia (WM). ( 1.2 ) Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. ( 1.3 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.1 Mantle Cell Lymphoma BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Waldenstr√∂m’s Macroglobulinemia BRUKINSA is indicated for the treatment of adult patients with Waldenstr√∂m’s macroglobulinemia (WM). 1.3 Marginal Zone Lymphoma BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.3) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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References: https://open.fda.gov/
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