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


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

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

Tamibarotene granted Fast Track Designation by the U.S. FDA

Apr 10, 2024
Learning objective: After reading this article, learners will be able to cite a new development in the treatment of acute myeloid leukemia.

Bookmark this article

On April 9, 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tamibarotene, an oral selective retinoic acid receptor alpha (RARA) agonist, in combination with azacitidine and venetoclax, for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with RARA overexpression, as detected by a U.S. FDA approved test, who are aged ≥75 years or ineligible for intensive chemotherapy.1 Tamibarotene was previously granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with AML.

Tamibarotene is currently being investigated in combination with venetoclax and azacitidine in the phase II SELECT-AML-1 trial (NCT04905407).1 Results from an interim analysis found that this triplet regimen was associated with a 100% complete remission/complete remission with incomplete count recovery rate vs 70% for venetoclax plus azacitidine alone, with a similar safety profile.1  Additionally, the ongoing phase III SELECT-MDS-1 trial (NCT04797780) is investigating the combination of tamibarotene and azacitidine for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS) with RARA overexpression.1 The AML Hub previously reported results from a phase II trial (NCT02807558) assessing tamibarotene in combination with azacitidine for the treatment of patients with newly diagnosed AML.

  1. Syros Pharmaceuticals. Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression. Published Apr 9, 2024. Accessed Apr 9, 2024.


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