FDA Approves Zanubrutinib for CLL, SLL

The U.S. Food and Drug Administration (FDA) has approved the Bruton’s tyrosine kinase inhibitor zanubrutinib for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The approval is based on two global phase III trials: the ALPINE study and SEQUOIA study. Both trials demonstrated superior efficacy for zanubrutinib in first-line and relapsed/refractory treatment settings for adult patients with CLL and SLL.

“We have seen striking data from the [zanubrutinib] development program demonstrating significant and consistent efficacy across CLL patient subtypes, including the high-risk del17p/TP53-mutated population, and regardless of treatment setting,” Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, said in a release from BeiGene, the manufacturer of the drug. “With extensive follow-up across the CLL development program and the combined results from the SEQUOIA and ALPINE trials, [zanubrutinib] is established as a new standard of care for CLL.”

With a median follow-up of 26.2 months in the SEQUOIA trial, zanubrutinib demonstrated a significant progression-free survival benefit versus bendamustine plus rituximab (hazard ratio, 0.42; 95% CI, 0.28-0.63; P<.0001).

In the ALPINE trial, zanubrutinib achieved a superior overall response rate versus ibrutinib in the relapsed/refractory treatment setting (80.4% vs 72.9%; P=.0264).

Source: BeiGene, January 2023