Midostaurin (Rydapt) approved for the treatment of newly diagnosed FLT3+ AML patients in Australia

This month, the Australian Government, Department of Health, Therapeutic Goods Administration, granted approval to Rydapt (midostaurin) in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are fms like tyrosine kinase 3 (FLT3) mutation-positive (FLT3+).1

In 2017, Rydapt was approved for newly diagnosed FLT3+ AML patients in the US and EU by the  U.S. Food and Drug Administration and European Commission (EC)respectively. The approval for Rydapt, a FLT3 inhibitor, was based on results from the phase III RATIFY trial (NCT00651261), which was a randomized trial in 717 newly diagnosed FLT3+ AML patients (median age = 47.9 years, range 18–59 years). In this study, patients were randomly assigned to receive either placebo or Rydapt® 50 mg orally twice daily on days 8–21 of each cycle of induction and consolidation chemotherapy followed by continuous daily midostaurin for up to 12 cycles. Median Overall Survival (OS) in patients receiving Rydapt® and placebo were 74.7 and 25.6 months, respectively (HR for death = 0.78, P = 0.009).2 More results of this study were reported here.2

  1. Public Summary of RYDAPT: Australian Government, Department of Health, Therapeutic Goods Administration. https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=86585B338DFD7781CA25829000422474&agid=(PrintDetailsPublic)&actionid=1 [Accessed 2018 May 23].
  2. Stone R.M. et al. Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation. N Engl J Med.2017 Jun 23. DOI: 10.1056/NEJMoa1614359. [Epub ahead of print].
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