CHMP recommends approval of Imbruvica + Rituxan for chronic lymphocytic leukaemia.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Imbruvica (ibrutinib) to include the combination with Rituxan (rituximab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

The Positive Opinion is based on data from the Phase III E1912 study, designed and conducted in the United States (U.S.) by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) 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 (median age 58) who were randomly assigned in a 2:1 ratio to receive ibrutinib plus rituximab (n=354) or the standard of care chemo-immunotherapy fludarabine, cyclophosphamide and rituximab (FCR) (n=175).

The primary study results were published in The New England Journal of Medicine, and the extended four-year median follow-up results were presented at the 2019 American Society of Hematology (ASH) Annual Meeting.