Posted by Michael Wonder on 27 Aug 2018
AbbVie announces Imbruvica (ibrutinib) plus rituximab approval by U.S. FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia, a rare type of blood cancer
27 August 2018 - Milestone represents ninth FDA approval for Imbruvica in less than five years since its initial approval.
AbbVie today announced that the U.S. FDA approved Imbruvica (ibrutinib) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma. With this approval, the Imbruvica prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. Imbruvica was first approved as a single agent therapy for WM in January 2015.
This new FDA approval is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial evaluating Imbruvica in combination with rituximab, versus rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM.
