Posted by Michael Wonder on 25 Jun 2018
Imbruvica (ibrutinib) supplemental new drug application accepted for review by U.S. FDA with potential to broaden treatment use as a combination treatment option with rituximab in Waldenström's macroglobulinemia, a rare form of blood cancer
25 June 2018 - The filing is based on data from the Phase 3 iNNOVATE study, which suggest that IMBRUVICA plus rituximab may improve outcomes across all lines of Waldenström's macroglobulinemia treatment, including patients with prior lines of therapy and various genetic factors, versus rituximab alone.
AbbVie today announced the U.S. FDA has accepted for priority review a supplemental new drug application for Imbruvica (ibrutinib) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia (WM), a rare and incurable form of blood cancer.
If approved, the application would expand the prescribing information of Imbruvica in WM beyond its current approved use as a single agent for all lines of therapy to include combination use with rituximab.
