Posted by Michael Wonder on 21 Apr 2020
Imbruvica (ibrutinib) receives 11th FDA approval
21 April 2020 - Granted under FDA's real-time oncology review pilot program, Project Orbis and priority review.
AbbVie today announced that the U.S. FDA approved the use of Imbruvica (ibrutinib) in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma
The approval is based on positive results from the landmark Phase 3 E1912 study, which was designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, part of the National Institutes of Health.
