What is the generic name?

IBRUTINIB

What is the Trade Name for IBRUTINIB?

Imbruvica

What are the Indications for IBRUTINIB?

• 1 INDICATIONS AND USAGE IMBRUVICA 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(s). Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.2 ). Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.3 ). Waldenstr√∂m‚Äôs macroglobulinemia (WM) ( 1.4 ). Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy ( 1.5 ). 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(s). Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.6 ). 1.1 Mantle Cell Lymphoma IMBRUVICA 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) [see Clinical Studies ( 14.1 )] . 1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1.3 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. 1.4 Waldenstr√∂m‚Äôs Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenstr√∂m‚Äôs macroglobulinemia (WM). 1.5 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 Clinical Studies ( 14.4 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.6 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.

References: https://open.fda.gov/