E1912 trial leads to FDA approval of ibrutinib-rituximab combo for untreated CLL

Patients aged 70 or younger with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma have a new treatment option — a combination of the targeted agent ibrutinib with the immunologic agent rituximab. The FDA has approved the combination based on data from E1912, a phase 3 trial that showed this combination provides better leukemia control, prolongs life, and has fewer side effects compared to standard care.