FDA Approves Brukinsa™ for Previously Treated Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) approved Brukinsa™ (zanubrutinib) capsules for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Tumor shrinkage with zanubrutinib

The approval was based on results from a single-arm clinical trial that included 86 patients with MCL who received at least one prior treatment. Among this cohort, 84% of patients had tumor shrinkage, with a median duration of response (DOR) of 19.5 months. This trial was supported by an additional single-arm study that included 32 patients, in whom 84% had tumor shrinkage, with a median DOR of 18.5 months.

Common adverse events associated with zanubrutinib included decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough.

The FDA said patients should be monitored for hemorrhage, signs and symptoms of infection, cytopenias, and cardiac arrhythmias during treatment.

Patients should use sun protection when taking zanubrutinib due to the risk of other malignancies, including skin cancer. The FDA also advised that women who are pregnant or breastfeeding do not take zanubrutinib.

The drugmaker, BeiGene Ltd, priced zanubrutinib at $12,935 for a 30-day supply, according to a report from Reuters.