All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your AML Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.

The AML Hub is an independent medical education platform, sponsored by Daiichi Sankyo, Jazz Pharmaceuticals, Kura Oncology, Roche and Syndax and has been supported through a grant from Bristol Myers Squibb. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

2018-05-23T13:57:52.000Z

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

May 23, 2018
Share:

Bookmark this article

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].

Your opinion matters

HCPs, what is your preferred format for educational content on the AML Hub?
15 votes - 80 days left ...

Related articles

Newsletter

Subscribe to get the best content related to AML delivered to your inbox