Mantle Cell Lymphoma: IMBRUVICA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL).
The efficacy and safety of Ibrutinib in patients with previously untreated mantle cell lymphoma who are eligible for intensive chemotherapy have not been established.
The efficacy and safety of Ibrutinib in patients with previously untreated mantle cell lymphoma with Ann Arbor stage I have not been established.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion: IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.
Waldenström's Macroglobulinemia: IMBRUVICA is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM).
Marginal Zone Lymphoma: IMBRUVICA is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
This indication is approved under accelerated approval based on overall response rate [see Pharmacology: Pharmacodynamics: Clinical Studies: Marginal Zone Lymphoma under Actions]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Chronic Graft versus Host Disease: IMBRUVICA is indicated for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
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