Posted by Michael Wonder on 28 Dec 2020
Imbruvica (ibrutinib) U.S. Prescribing Information updated to include long-term data for Waldenström's macroglobulinemia
23 December 2020 - Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated Imbruvica plus rituximab significantly prolonged progression-free survival versus rituximab alone in adults with Waldenström's macroglobulinemia.
AbbVie announced today that the U.S. FDA approved the update of the Imbruvica (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström's macroglobulinemia, based on the final analysis of the Phase 3 iNNOVATE trial.
