Posted by Michael Wonder on 23 Jun 2020
Imbruvica (ibrutinib) seeks to expand U.S. label with long-term data in Waldenström's macroglobulinaemia
23 June 2020 - Submission is based on results of more than five years of follow-up data from the Phase 3 iNNOVATE clinical trial evaluating Imbruvica in combination with rituximab for patients with Waldenström's macroglobulinaemia.
AbbVie today announced that the U.S. FDA will review a supplemental new drug application for Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinaemia, a rare and incurable type of non-Hodgkin's lymphoma.
