Application Nr Approved Date Route Status External Links
NDA210259 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Calquence 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 Confirmatory Trials. (1.1, 14.1) • Chronic Lymphocytic Leukemia (cll) Or Small Lymphocytic Lymphoma (sll). (1.2) 1.1 Mantle Cell Lymphoma Calquence 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 Confirmatory Trials. 1.2 Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma Calquence Is Indicated For The Treatment Of Adult Patients With Chronic Lymphocytic Leukemia (cll) Or Small Lymphocytic Lymphoma (sll) .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Acalabrutinib

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