1L=first line; 2L=second line; BR=bendamustine+rituximab; BTK=Bruton's tyrosine kinase; ORR=overall response rate; PFS=progression-free survival.
*In an exploratory analysis, the median follow-up time was 44.4 months for Cohort 1 and 42.9 months for Cohort 2.3
BTK=Bruton's tyrosine kinase. R/R=relapsed/refractory.
INDICATIONS
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:
- • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- • Waldenström's macroglobulinemia (WM)
- • Mantle cell lymphoma (MCL) who have received at least one prior therapy
- • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
The MCL and MZL indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage
Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients.
Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.
Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Please see complete Important Safety Information and full Prescribing Information.
POWERFUL AND SUSTAINED RESPONSES1,2
POWERFUL AND DURABLE RESPONSES1,2
*In an exploratory analysis, the median follow-up time was 44.4 months for Cohort 1 and 42.9 months for Cohort 2.3
BTK=Bruton's tyrosine kinase. R/R=relapsed/refractory.