Zanubrutinib received U.S. Food and Drug Administration approval for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL).
Approval was based on two studies, one for treatment-naïve patients and one for patients with relapsed or refractory CLL/SLL, dubbed SEQUOIA and ALPINE, respectively. Common adverse reactions found across both trials included decreased platelet count, decreased neutrophil count, upper respiratory tract infection, hemorrhage, and musculoskeletal pain. Secondary primary malignancies occurred in 13% of patients, atrial fibrillation or flutter was observed in 3.7%, and grade 3 or higher ventricular arrythmias in 0.02%.
“Thanks to research that has delivered innovative and effective medicines, people with CLL can remain on therapy for years, so tolerability is an important consideration. I’m pleased that the approval of zanubrutinib provides a new [Bruton tyrosine kinase inhibitor] option for people with CLL/SLL, with demonstrated efficacy, as well as being very well tolerated long-term,” said Brian Koffman, MD, chief medical officer and executive vice-president at the CLL Society.
Sources: FDA, January 19, 2023; Businesswire, January 19, 2023.
