FDA Approval Sought for Ibrutinib/Rituximab in Frontline CLL/SLL

November 8, 2019 – A supplemental new drug application (sNDA) has been submitted to the FDA for ibrutinib for use in combination with rituximab for the first-line treatment of patients ≤70 years old with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The sNDA is based on findings from the phase III E1912 trial, in which the combination demonstrated an 83% reduction in the risk of death compared with standard fludarabine, cyclophosphamide … (leggi tutto)