20 January 2020 - Application supported by the Phase 3 E1912 study evaluating the use of ibrutinib in combination with rituximab, compared to the chemo-immunotherapy regimen of fludarabine, cyclophosphamide and rituximab in patients aged 70 years or younger who have previously untreated chronic lymphoytic leukaemia.

Janssen today announced the submission of a Type II variation application to the EMA seeking to expand the label of Imbruvica (ibrutinib) to include ibrutinib in combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukaemia (CLL).

The submission is supported by data from the Phase 3 E1912 study, designed and conducted in the United States by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), which is part of the U.S. National Institutes of Health. The study evaluated 529 patients with previously untreated CLL aged 70 years or younger, who were randomly assigned in a 2:1 ratio to receive ibrutinib plus rituximab (n=354) or the chemo-immunotherapy (n=175). The primary endpoint was progression-free survival and one of the secondary endpoints was overall survival.

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