Revumenib’s FDA Approval and Clinical Implications

Author(s):

Thomas W. LeBlanc, MD, MA, MHS, FAAHPM, FASCO ,James Blachly, MD

Panelists discuss the FDA approval of revumenib for relapsed/refractory acute leukemia (R/R AML) with KMT2A translocation, reviewing the eligible patient population and the mechanism of action of this menin inhibitor, while exploring key findings from the AUGMENT-101 trial and how this approval may impact treatment approaches in both the R/R and broader AML settings.

EP: 1.Treatment Strategies for Relapsed/Refractory AML Patients

EP: 2.Treatment Goals and Unmet Needs in R/R AML

EP: 3.Navigating Challenges in Second- and Third-Line AML Therapy

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EP: 4.Revumenib’s FDA Approval and Clinical Implications

Video content above is prompted by the following:

Provide details of the FDA approval on November 15, 2024, for revumenib in R/R acute leukemia with KMT2A translocation.
Briefly review the population, and which patients can be treated with this new therapy.
Briefly discuss the mechanism of action of this menin inhibitor, revumenib.
Briefly comment on key takeaways from AUGMENT-101 efficacy and safety data that led to FDA approval
What aspects of revumenib’s efficacy and safety profile stand out compared with other approved agents in AML?
How does this FDA approval impact your treatment approach for AML overall (including R/R setting)?