ASH Clinical News Advances in Hematology Research & Patient Care: Hi | Page 6

Brief Summary of Prescribing Information for IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib) capsules, for oral use
See package insert for Full Prescribing Information
INDICATIONS AND USAGE
Mantle Cell Lymphoma: IMBRUVICA is 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 [see Clinical
Studies (14.1) in Full Prescribing Information].
Chronic Lymphocytic Leukemia: IMBRUVICA is indicated for the treatment
of patients with chronic lymphocytic leukemia (CLL) who have received
at least one prior therapy [see Clinical Studies (14.2) in Full Prescribing
Information].
Chronic Lymphocytic Leukemia with 17p deletion: IMBRUVICA is indicated
for the treatment of patients with chronic lymphocytic leukemia (CLL) with
17p deletion [see