FDA approves zanubrutinib for CLL or SLL

Based on efficacy in treatment-naive patients with CLL/SLL, zanubrutinib was approved by the FDA on January 19, 2023 based on the SEQUOIA trial. With a main efficacy outcome measure of progression-free survival (PFS), 479 previously untreated patients were randomly assigned 1:1 to zanubrutinib (until disease progression or unacceptable toxicity) or bendamustine plus rituximab for six cycles. Median PFS was not reached in the study arm vs. 33.7 months in the combination arm (HR = 0.42; 95% CI: 0.28, 0.63; P ≤ 0.0001). An Assessment Aid was used, and the application was granted Orphan Drug status.