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Gilteritinib FDA | 合法藥品大搜索

Gilteritinib FDA

XOSPATAisindicatedforthetreatmentofadultpatientswhohaverelapsedorrefractoryacutemyeloidleukemia.(AML)withaFMS-liketyrosinekinase3(FLT3) ...,ThesafetyevaluationofXOSPATAisbasedon292patientswithrelapsedorrefractoryAMLtreatedwith120mggilteritinibdaily.Themediandurationof ...,2018年12月21日—PersonswithdisabilitieshavingproblemsaccessingthePDFfilesbelowmaycall(301)796-3634forassistance.FDAApprovalLetterandLabeling.,2018年11月28日—OnNovember28,2018,theFoodandDrugAdministrationapprovedgilteritinib(...

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gilteritinib | 合法藥品大搜索
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia. (AML) with a FMS-like tyrosine kinase 3 (FLT3) ... Read More
HIGHLIGHTS OF PRESCRIBING INFORMATION These ... | 合法藥品大搜索
The safety evaluation of XOSPATA is based on 292 patients with relapsed or refractory AML treated with 120 mg gilteritinib daily. The median duration of ... Read More
Drug Approval Package | 合法藥品大搜索
2018年12月21日 — Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling. Read More
FDA approves gilteritinib for relapsed or refractory acute ... | 合法藥品大搜索
2018年11月28日 — On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult ... Read More
FDA approves addition of survival data to gilteritinib label for ... | 合法藥品大搜索
On May 29, 2019, the Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, ... Read More
FDA approves treatment for adult patients who have relapsed ... | 合法藥品大搜索
2018年11月28日 — The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia ... Read More
FDA Approval Summary | 合法藥品大搜索
由 ED Pulte 著作 — On November 28, 2018, the FDA approved gilteritinib (Xospata; Astellas), a small-molecule FMS-like tyrosine kinase 3 (FLT3) inhibitor, for ... Read More
FDA Approval Summary | 合法藥品大搜索
由 ED Pulte 著作 · 2021 — FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation. E. Dianne Pulte, Kelly J. Norsworthy, ... Read More
Xospata (gilteritinib) FDA Approval History | 合法藥品大搜索
2018年11月28日 — Xospata (gilteritinib) is a FLT3/AXL kinase inhibitor indicated for the treatment of patients who have relapsed or refractory acute myeloid ... Read More
FDA Approves Update to Gilteritinib AML Label to Include OS ... | 合法藥品大搜索
2019年5月30日 — Gilteritinib was initially approved by the FDA in November 2018; the decision was based on an interim analysis of CR/CRh rate, duration of CR/ ... Read More
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