FDA Approves Update to Gilteritinib AML Label to Include OS ... | 合法藥品大搜索

2019年5月30日—GilteritinibwasinitiallyapprovedbytheFDAinNovember2018;thedecisionwasbasedonaninterimanalysisofCR/CRhrate,durationofCR/ ...

A supplemental new drug application has been approved by the FDA to update the label for gilteritinib (Xospata) to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractoryFLT3-mutant acute myeloid leukemia (AML).1

Results from the phase III trial showed the median OS in patients who were treated with gilteritinib was 9.3 months (95% CI, 7.7-10.7) compared with 5.6 months in those who received salvage chemotherapy (95% CI, 4.7-7.3), which led to a 36% reduction in the risk of death (HR, 0.637; 95% CI, 0.490-0.830; P = .007).2

Moreover, at the interim analysis, the complete remission (CR)/complete remission with partial hematologic recovery (CRh) in the gilteritinib arm was 21% (95% CI, 14.5-28.8).

"The ADMIRAL trials overall survival findings are encouragin...