Brukinsa

Product manufactured by Beigene Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA213217 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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. 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 ) 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Zanubrutinib

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