Posted by Michael Wonder on 28 Jan 2019
AbbVie announces U.S. FDA approval of Imbruvica (ibrutinib) plus obinutuzumab (Gazyva) - first chemotherapy-free, anti-CD20 combination regimen approved for chronic lymphocytic leukaemia/small lymphocytic lymphoma in previously untreated patients
28 January 2019 - FDA approval is based on positive Phase 3 iLLUMINATE (PCYC-1130) study results, which demonstrated Imbruvica plus obinutuzumab significantly prolonged progression-free survival versus the National Comprehensive Cancer Network Clinical Practice Guidelines Category 1 treatment of chlorambucil plus obinutuzumab.
AbbVie today announced that the U.S. FDA approved the use of Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).
The latest FDA approval expands the use of IMBRUVICA, which can already be administered as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients.
