Posted by Michael Wonder on 28 Jul 2020
Janssen receives CHMP positive opinion for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
24 July 2020 - Positive opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment of patients with chronic lymphocytic leukaemia.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the EMA’s CHMP has issued a positive opinion recommending marketing authorisation for Imbruvica (ibrutinib) to include the combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
The positive opinion is based on data from the Phase 3 E1912 study, designed and conducted in the US by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, which is part of the U.S. National Institutes of Health.
