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Midostaurin: First Global Approval
online resourceposted on 09.04.2018, 01:42 by Esther S. Kim
The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. E. S. Kim is a salaried employee of Adis, Springer SBM.
Additional information about this Adis Drug Review can be found here.
Midostaurin (Rydapt®) is a multikinase inhibitor being developed by Novartis Pharmaceuticals. In April 2017, midostaurin was approved in the USA for the treatment of adult patients with newly diagnosed, FMS-like tyrosine kinase 3 (FLT3) mutation-positive acute myeloid leukaemia (AML) [in combination with standard cytarabine and daunorubicin induction, and cytarabine consolidation], or aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL) [collectively known as advanced SM]. The article summarizes the milestones in the development of midostaurin leading to this first global approval.
Access to the full article can be found here.
© Springer International Publishing AG, part of Springer Nature 2017