FDA Approves Label Update for Zanubrutinib for CLL

The US Food and Drug Administration (FDA) has approved a label update for zanubrutinib for the treatment of chronic lymphocytic leukemia (CLL) to include progression-free survival (PFS) results from the ALPINE trial.

ALPINE is a phase III trial that compared zanubrutinib with ibrutinib in patients with pretreated relapsed or refractory CLL. The Bruton’s tyrosine kinase inhibitor was approved in the United States in January 2023 based on superior overall response rates compared with ibrutinib (80.4% vs 72.9%; P=.0264).

The label update includes results from a median follow-up of 31 months, in which zanubrutinib demonstrated superior PFS compared with ibrutinib (hazard ratio, 0.65; 95% CI, 0.49-0.86;  P=.0024). Zanubrutinib also demonstrated a favorable cardiac safety profile, with significantly lower rates of atrial fibrillation and flutter (5.2% vs 13.3%) and zero deaths from cardiac disorders versus six with ibrutinib (0% vs 1.9%).

“The ALPINE trial is the first and only study to demonstrate PFS superiority in a head-to-head comparison versus ibrutinib in CLL,” said Mehrdad Mobasher, MD, MPH, Chief Medical Officer of Hematology at BeiGene, the manufacturer of the drug. “When making treatment decisions, it is critical that physicians and patients understand the totality of data supporting [zanubrutinib’s] robust efficacy and differentiated safety in CLL.”