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FDA approves addition of survival data to gilteritinib label for ... | 合法藥品大搜索

FDA approves addition of survival data to gilteritinib label for ...

OnMay29,2019,theFoodandDrugAdministrationapprovedtheadditionofoverallsurvivaldatainlabelingforgilteritinib(XOSPATA,AstellasPharmaUS, ...

 FDA approves addition of survival data to gilteritinib label for ...

On May 29, 2019, the Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Approval was based on the ADMIRAL trial (NCT02421939), which included 371 adult patients with relapsed or refractory AML having a FLT3 ITD, D835, or I836 mutation by the LeukoStrat® CDx FLT3 Mutation Assay. Patients were randomized (2:1) to receive XOSPATA 120 mg once daily (n=247) over continuous 28-day cycles or prespecified salvage chemotherapy (n=124). Salvage chemotherapy included either intensive cytotoxic chemotherapy or a low-intensity regimen.

For the analysis, overall survival (OS) was mea...

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Gilteritinib FDA NCT02421939 Xospata fda ADMIRAL trial XOSPATA Midostaurin FDA Midostaurin 仿單 TIBSOVO Gilteritinib FDA Xospata fda NCT02421939 ADMIRAL trial Midostaurin FDA TIBSOVO Midostaurin 仿單 XOSPATA PRESCRIBING information midostaurin fda approval aml gilteritinib fda approval RYDAPT Midostaurin fever Midostaurin ema quizartinib fda approval diazepam 2mg功效 核黃素功能 薪保賜康結石 sightclear副作用 保力達副作用 維 士 比 行銷 Clotrimazole 500mg 用法 Mikelan
FDA Approval Summary | 合法藥品大搜索
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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
Gilteritinib | 合法藥品大搜索
由 S Dhillon 著作 · 2019 · 被引用 46 次 — Gilteritinib is approved in Japan for the treatment of relapsed or refractory AML with FLT3 mutation. Recently, it was also approved in the USA for the ... Read More
gilteritinib | 合法藥品大搜索
XOSPATA® (gilteritinib) tablets, for oral use. Initial U.S. Approval: 2018. WARNING: DIFFERENTIATION SYNDROME. See full prescribing information for complete ... 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 Approval Summary | 合法藥品大搜索
由 ED Pulte 著作 · 2021 — On November 28, 2018, the FDA approved gilteritinib (Xospata; Astellas), a small-molecule FMS-like tyrosine kinase 3 (FLT3) inhibitor, ... 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
Xospata (Gilteritinib) First Drug Approved as Monotherapy for ... | 合法藥品大搜索
由 LA Raedler 著作 — On November 28, 2018, the FDA approved oral gilteritinib (Xospata; Astellas Pharma), a tyrosine kinase inhibitor of several receptor kinases, including FLT3 ... Read More
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