The FDA approves using ibrutinib and rituximab (IR) in combination for the frontline treatment of patients age 70 and younger with chronic lymphocytic leukemia (CLL). This approval is based on the practice-changing randomized phase 3 trial E1912. Not only did E1912 find that IR provides better leukemia control, but it also prolongs life and has fewer side effects than previous standard chemo-immunotherapy, fludarabine, cyclophosphamide, and rituximab (FCR) (Shanafelt TD. N Engl J Med. August 2019). As a result, E1912 eliminated the need for chemotherapy in these patients.
Now, long-term outcomes are available. After a median follow-up of 6 years, IR led to superior progression-free survival (PFS) compared to FCR and excellent overall survival. In addition, most CLL patients tolerate continuous ibrutinib therapy beyond 5 years. Shanafelt TD. Blood. July 2022