The FDA expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab (Rituxan) for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).1
The review was conducted under Project Orbis, and the FDA is collaborating with the Australian Therapeutic Goods Administration, Health Canada, and Swissmedic as they continue to review the application.
The approval was based on the phase III E1912 trial, which was a multicenter, open-label, activity-controlled trial which randomized patients in a 2:1 fashion to either ibrutinib with rituximab or a combination of fludarabine (Fludara), cyclophosphamide, and rituximab (FCR). The primary endpoint for the trial was progression-free survival (PFS), and one of the secondary endpoints was overall survival (OS).2
The primary study results were published in The New…