MedPath

Midostaurin

Generic Name
Midostaurin
Brand Names
Rydapt
Drug Type
Small Molecule
Chemical Formula
C35H30N4O4
CAS Number
120685-11-2
Unique Ingredient Identifier
ID912S5VON

Overview

Midostaurin (as Rydapt) is a multitarget kinase inhibitor for the treatment for adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3. It was initially characterized as a potential broad-spectrum antineoplastic agent, with activity toward diverse solid and hematopoietic tumors . It was approved on April 28, 2017 and has shown to increase the overall survival rate in patients with AML as an adjunct therapy along with chemotherapeutic agents.

Background

Midostaurin (as Rydapt) is a multitarget kinase inhibitor for the treatment for adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3. It was initially characterized as a potential broad-spectrum antineoplastic agent, with activity toward diverse solid and hematopoietic tumors . It was approved on April 28, 2017 and has shown to increase the overall survival rate in patients with AML as an adjunct therapy along with chemotherapeutic agents.

Indication

Investigated for use/treatment in adult patients with high-risk acute myeloid leukemia (AML) who are FLT3 mutation-positive, agressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Associated Conditions

  • Acute Myeloid Leukemia
  • Aggressive Systemic Mastocytosis
  • Mast Cell Leukemia (MCL)
  • Systemic Mastocytosis

FDA Approved Products

RYDAPT
Manufacturer:Novartis Pharmaceuticals Corporation
Route:ORAL
Strength:25 mg in 1 1
Approved: 2017/04/28
NDC:0078-0698

Singapore Approved Products

RYDAPT SOFT CAPSULE 25MG
Manufacturer:Catalent Germany Eberbach GmbH, Catalent Germany Schorndorf GmbH (Primary and Secondary packager)
Form:CAPSULE, LIQUID FILLED
Strength:25mg
Online:Yes
Approved: 2018/07/30
Approval:SIN15518P

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