IMBRUVICA® (ibrutinib) is the first and only
FDA-approved therapy for use in patients
with Waldenström’s macroglobulinemia (WM)
IMBRUVICA® is approved for use in 4 indications
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.
Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Chronic lymphocytic leukemia with 17p deletion.
Waldenström’s macroglobulinemia (WM).
ADVERSE REACTIONS
The most common adverse reactions (≥25%) in patients with
B-cell malignancies (MCL, CLL, WM) were thrombocytopenia*
(57%, 52%, 43%), neutropenia* (47%, 51%, 44%), diarrhea
(51%, 48%, 37%), anemia* (41%, 36%, 13%), fatigue (41%,
28%, 21%), musculoskeletal pain (37%, 28%†, NA‡), bruising
(30%, 12%†, 16%†), nausea (31%, 26%, 21%), upper respiratory
tract infection (34%, 16%, 19%), and rash (25%, 24%†, 22%†).
*Based on adverse reactions and/or laboratory measurements
(noted as platelets, neutrophils, or hemoglobin decreased).
†
Includes multiple ADR terms.
‡
Not applicable; no associated ADRs.
The most common Grade 3 or 4 non-hematological adverse
reactions (≥5%) in MCL patients were pneumonia (7%),
abdominal pain (5%), atrial fibrillation (5%)