Posted by Michael Wonder on 17 Oct 2018
AbbVie announces supplemental new drug application accepted for priority review by U.S. FDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for previously untreated chronic lymphocytic leukaemia
17 October 2018 - The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer progression-free survival for Imbruvica plus obinutuzumab versus chlorambucil plus obinutuzumab in CLL/SLL.
AbbVie today announced the U.S. FDA has accepted its supplemental new drug application for priority review for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the application is approved, the use of Imbruvica with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL.
Imbruvica is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab.
