Commenting on this study, Jan A. Burger, MD, PhD, Associate Professor in the Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, and first author of one of the ibrutinib studies presented at the 2012 Annual Meeting of the American Society of Hematology, said that taken together, evidence supporting ibrutinib’s efficacy thus far is impressive.

“Ibrutinib is amazingly active, even in high-risk patients, who have few other alternatives. When a patient with 17p deletion relapses, treatment success is limited. These patients die with progressive disease within a year or two, and often within months. With ibrutinib, we still don’t reach median survival after 1 year,” Dr. Burger noted.

With about 500 CLL patients treated to date, Dr. Burger is confident that ibrutinib fulfills an unmet medical need. “Suddenly we have a safe oral agent with dramatic results. We hope the drug will be approved by FDA sooner rather than later. Otherwise, patients who need this therapy won’t be able to get it.”

Dr. Burger noted that ibrutinib received an FDA breakthrough designation for CLL with 17p deletion, mantle cell lymphoma, and Waldenström’s macroglobulinemia. ■

Disclosure: Dr. Burger has received research funding from Pharmacyclics and Gilead.