Dr. Byrd on Long-term Safety Data With Ibrutinib in CLL

John C. Byrd, MD, D. Warren Brown Chair of Leukemia Research, professor of medicine, Medicinal Chemistry and Veterinary Biosciences, director, Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center, discusses long-term safety data with ibrutinib (Imbruvica) as treatment for patients with chronic lymphocytic leukemia (CLL).

With any new drug that is administered for a long time, emerging toxicities become a concern, Byrd explains. However, with the long-term follow-up of the RESONATE study of ibrutinib, the toxicities observed are very similar as to what was seen in the phase II study. These include an increased risk of atrial fibrillation, increased bruising, bleeding, and rash; nevertheless, they have not increased over time with the initial report.

What is notable, however, are the infections over time that decrease, which likely suggest that ibrutinib is improving the immune system. Overall, this longer follow-up shows that, for patients with relapsed CLL, ibrutinib remains a game changer for this disease, Byrd concludes.