Opinion|Videos|January 10, 2025
Revumenib’s FDA Approval and Clinical Implications
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.
Advertisement
Episodes in this series
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)?
Advertisement
Related to this article
Many patients with IDH-mutant glioma continued to receive vorasidenib as directed in the real-world GLIO-ADHERE claims analysis.
Mirdametinib produced stable disease or partial responses in adults and children with plexiform neurofibromas who had received another MEK inhibitor.
Longer follow-up of the phase 3 INDIGO trial showed that vorasidenib lowered seizure rates in IDH-mutant glioma, an effect driven by oligodendroglioma.
Many patients with BRAF-altered pediatric low-grade glioma stayed off therapy after planned tovorafenib cessation in the 4-year FIREFLY-1 update.
Sarah Goldberg, MD, MPH, details how clinicians can choose among frontline regimens, act on resistance mechanisms, and incorporate ADCs and newer agents across the spectrum of EGFR-mutated NSCLC.
The FDA approved pimicotinib for tenosynovial giant cell tumor, accepted a gedatolisib filing in advanced breast cancer, and more.
Serial amino acid PET flagged responses earlier than MRI in IDH-mutant glioma treated with vorasidenib, interim data show.
Longer mirdametinib treatment increased confirmed and deep responses as treatment-related adverse effects declined in neurofibromatosis type 1 tumors.
Advertisement
Advertisement
Trending on OncLive
1
Dr Johnson on Immune Activation With Indoximod-Based Chemo-Immunotherapy in Recurrent Ependymoma
2
Tovorafenib Sustains Treatment-Free Intervals in R/R BRAF-Altered Pediatric Low-Grade Glioma
3
Dr Miller on Whole Genome Sequencing of CSF ctDNA in High-Grade Glioma
4
Patient Preferences Steer Decisions as Options Multiply Across EGFR-Mutated NSCLC
5