MILAN – The Food and Drug Administration has given full approval for ibrutinib for patients with chronic lymphocytic leukemia who have received at least one prior therapy and for those who have a deletion in chromosome 17 (17p deletion) and may or may not have received previous treatment.
At the annual congress of the European Hematology Association, Dr. Peter Hillmen discusses the results he presented from RESONATE, the study used to convert conditional, accelerated approval to full approval. The study evaluated daily ibrutinib monotherapy versus the anti-CD20 antibody ofatumumab, for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Dr. Hillmen, professor of experimental hematology at the University of Leeds, England, also outlines some of the research in the works to evaluate ibrutinib as frontline therapy for patients with CLL and the possibility of chemotherapy-free regimens. He disclosed a consultancy role and honoraria from Pharmacyclics.