FDA approves sNDA for Xospata

Japanese drug major Astellas Pharma (TYO: 4503) today announced that the US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US 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 leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation.

“The ADMIRAL trial’s overall survival (OS) findings are encouraging for patients and families impacted by relapsed/refractory FLT3 mutation-positive AML,” Dr said Alexander Perl, Abramson Cancer Center, University of Pennsylvania. “The data underscore the importance of single-agent Xospata for this patient population that, until recently, had few remaining treatment options,” he noted.