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FDA approves new combination treatment for acute myeloid ... | 合法藥品大搜索

FDA approves new combination treatment for acute myeloid ...

2017年4月28日—TheU.S.FoodandDrugAdministrationtodayapprovedRydapt(midostaurin)forthetreatmentofadultpatientswithnewlydiagnosedacute ...

 FDA approves new combination treatment for acute myeloid ...

For Immediate Release: April 28, 2017

The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.   AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute estimated that approximately 19,930 people would be diagnosed with AML in 2016 and 10,430 were projected to die of the disease.

“Rydapt is the first targeted therapy to...

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Midostaurin | 合法藥品大搜索
2017年4月28日 — FDA also approved midostaurin for the treatment of adults with aggressive systemic mastocytosis (SM), SM with associated hematological ... Read More
FDA approves new combination treatment for acute myeloid ... | 合法藥品大搜索
2017年4月28日 — The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute ... Read More
RYDAPT (midostaurin) | 合法藥品大搜索
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and ... Read More
Label (PDF) | 合法藥品大搜索
Information on FDA-approved tests for the detection of FLT3 mutation in AML is ... RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to ... Read More
Draft Guidance on Midostaurin Active Ingredient | 合法藥品大搜索
This draft guidance, when finalized, will represent the current thinking of the Food and Drug. Administration (FDA, or the Agency) on this topic. It does not ... Read More
RYDAPT (midostaurin) Capsules | 合法藥品大搜索
Date created: January 5, 2017. Back to Top Drugs@FDA. Vision impaired people having problems accessing certain pages of a PDF file may call (301) ... Read More
RYDAPT (midostaurin) capsules | 合法藥品大搜索
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and ... Read More
Rydapt (midostaurin) FDA Approval History | 合法藥品大搜索
FDA approval history for Rydapt (midostaurin) used to treat Acute Myeloid Leukemia. Supplied by Novartis. Read More
FDA Approval Summary | 合法藥品大搜索
由 YL Kasamon 著作 · 2018 · 被引用 21 次 — Midostaurin is the only U.S. Food and Drug Administration‐approved therapy for patients with systemic mastocytosis with associated hematological neoplasm and​ ... Read More
FDA Approves RYDAPT® (Midostaurin) | 合法藥品大搜索
On April 28, 2017, the United States Food and Drug Administration (FDA) approved RYDAPT (midostaurin) for the treatment of adult patients with: Newly ... Read More
相關資訊整理

【療德妥軟膠囊25毫克】於新確診為FLT3突變陽性的急性骨髓性白血病(AML)成人病患之標準前導(daunorubicin併用cytarabine)與鞏固性化療(高劑量cytarabine)時合併使用Rydapt。

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