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Opinion|Videos|January 10, 2025

Revumenib’s FDA Approval and Clinical Implications

Author(s)Thomas W. LeBlanc, MD, MA, MHS, FAAHPM, FASCO , James Blachly, MD, Aaron Goldberg, MD, PhD Memorial Sloan Kettering Cancer Center

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.

Episodes in this series

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

EP. 1 Treatment Strategies for Relapsed/Refractory AML Patients

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

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

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

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

EP. 4 Revumenib’s FDA Approval and Clinical Implications

EP. 4 Revumenib’s FDA Approval and Clinical Implications

EP. 5 Efficacy and Potential of Revumenib in KMT2A-Translocated Leukemia

EP. 5 Efficacy and Potential of Revumenib in KMT2A-Translocated Leukemia

EP. 6 Adverse Event Management and Patient Safety With Revumenib

EP. 6 Adverse Event Management and Patient Safety With Revumenib

EP. 7 MRD Testing and the Role of Revumenib in Treatment Response

EP. 7 MRD Testing and the Role of Revumenib in Treatment Response

EP. 8 Integrating Revumenib Into Current R/R AML Treatment Paradigms

EP. 8 Integrating Revumenib Into Current R/R AML Treatment Paradigms

EP. 9 Genetic Testing and Molecular Profiling in AML

EP. 9 Genetic Testing and Molecular Profiling in AML

EP. 10 Emerging Combination Strategies and Preclinical Findings

EP. 10 Emerging Combination Strategies and Preclinical Findings

EP. 11 Future Perspectives on Menin Inhibitors in Acute Leukemias

EP. 11 Future Perspectives on Menin Inhibitors in Acute Leukemias

EP. 12 Closing Perspectives on R/R AML Treatment Advances

EP. 12 Closing Perspectives on R/R AML Treatment Advances

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)?

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