Posted by Michael Wonder on 31 May 2019
U.S. FDA approves supplemental new drug application adding overall survival data for Xospata (gilteritinib)
30 May 2019 - Phase 3 ADMIRAL trial showed patients treated with Xospate demonstrated longer overall survival than those who received salvage chemotherapy.
Astellas Pharma today announced that the U.S. FDA approved a supplemental new drug application to update the U.S. product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial.
The data demonstrated improvement in overall survival in those treated with gilteritinib monotherapy versus salvage chemotherapy in adult patients with relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukaemia with an FMS-like tyrosine kinase 3 mutation.
