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.
2024-03-28T15:27:13.000Z

Priority Review of a new drug application for revumenib in the treatment of patients with R/R KMT2Ar AML and ALL

Mar 28, 2024
Share:
Learning objective: After reading this, learners will be able to cite a new development in the treatment of acute myeloid leukemia.

Bookmark this article

On March 26, 2024, the U.S. Food and Drug Administration (FDA) granted revumenib, a first-in-class menin inhibitor, Priority Review for a New Drug Application that aims to treat patients with relapsed/refractory (R/R) KMT2A-rearranged acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Also, it has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024. This is as a result of positive data from the AUGMENT-101 trial (NCT04065399).

AUGMENT-101 trial1

AUGMENT-101 investigated revumenib for the treatment of adult and pediatric patients with KMT2Ar AML and ALL. The study met its primary endpoint and had positive results from secondary endpoints (Figure 1).

Figure 1. Primary and secondary endpoints at the interim analysis stage of AUGMENT-101* 

CR/CRh, complete response/complete response with partial hematologic recovery; MRD, minimal residual disease; OR, overall response.
*Adapted from Syndax.1
Patients included who achieved a CR/CRh and were assessed for MRD.
Patients included from the efficacy-evaluable subgroup who achieved an overall response.

 

Conclusion

Priority Review of this New Drug Application could provide an alternative treatment option for patients who have R/R KMT2A-rearranged AML and ALL. This will address the unmet clinical need for patients with ALL and AML after first-line treatment relapse.

  1. Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukemia. https://ir.syndax.com/news-releases/news-release-details/syndax-announces-fda-priority-review-nda-revumenib-treatment. Published March 26, 2024. Accessed March 28, 2024.

Newsletter

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