Ibrutinib, is a kinase inhibitor indicated for the treatment of patients with:
• Mantle cell lymphoma (MCL), who have received at least one prior therapy
Accelerated approval was granted for this indication based on overall response rate.
Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
• Chronic lymphocytic leukemia (CLL), who have received at least one prior therapy
• Chronic lymphocytic leukemia with 17p deletion
• Waldenström’s macroglobulinemia (WM)
• Mantle cell lymphoma (MCL), who have received at least one prior therapy
Accelerated approval was granted for this indication based on overall response rate.
Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
• Chronic lymphocytic leukemia (CLL), who have received at least one prior therapy
• Chronic lymphocytic leukemia with 17p deletion
• Waldenström’s macroglobulinemia (WM)
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