MONDAY, Nov. 18, 2019 (HealthDay News) -- Brukinsa (zanubrutinib), a kinase inhibitor, has been granted accelerated approval for the treatment of adults with mantle cell lymphoma who have received at least one previous therapy, the U.S. Food and Drug Administration announced last week.
The recommended dose of Brukinsa capsules is 160 mg orally twice daily or 320 mg orally once daily. The prescribing information lists warnings and precautions for hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and embryo-fetal toxicity.
Approval was based on a single-arm clinical trial of Brukinsa involving 86 patients with mantle cell lymphoma who had received at least one previous treatment. Tumor shrinkage occurred in 84 percent of patients, and median duration of response was 19.5 months. In another single-arm trial of 32 patients, tumor shrinkage occurred in 84 percent of patients, and median response duration was 18.5 months.
The most commonly reported side effects of Brukinsa included decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough. Clinicians should monitor patients taking Brukinsa for hemorrhage, signs and symptoms of infection, cytopenias, and cardiac arrhythmias. Patients should also use sun protection when taking Brukinsa because of a risk for other malignancies, including skin cancer.
Approval was granted to BeiGene USA.