Revuforj® (revumenib)
FOR IMMEDIATE RELEASE:
Onco360® Has Been Selected as a National Specialty Pharmacy Partner for Revuforj® (revumenib)
Louisville, KY — November 19, 2024 – Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a national pharmacy partner by Syndax Pharmaceuticals for Revuforj® (revumenib), as the first and only menin inhibitor approved for the treatment of relapsed or refractory (R/R) acute leukemias with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.1 This indication was approved based on the Phase I/II AUGMENT-101 (NCT04065399) trial, which evaluated single-agent revumenib in 104 children and adults with previously treated acute leukemias associated with KMT2A rearrangements.2 KMT2A rearrangements occur in approximately 10% of acute leukemias In children and adult patients.3
Revuforj® (revumenib) is a menin inhibitor and blocks the interaction of both wild-type KMT2A and KMT2A fusion proteins with menin. The binding of KMT2A fusion proteins with menin is involved in KMT2A-rearranged acute leukemias through activation of a leukemogenic transcriptional pathway.
“Onco360 is grateful for the opportunity to partner with the team at Syndax and add Revuforj® to our comprehensive portfolio of cancer and rare disease therapies,” said Benito Fernandez.
The FDA approval of Revuforj® is based on the results of 104 patients with R/R acute leukemias with a KMT2A translocation who were treated with Revumenib in the Phase 1/2 AUGMENT-101 trial. Revuforj administration resulted in a 21.2% rate of complete remission (CR) plus CR with partial hematologic recovery (CRh). The most common adverse reactions occurring in ≥20% of patients consisted of hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.
Please see the full Prescribing Information for Revuforj®
Media Contact: Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332
References:
1Revuforj (Revumenib) [Package Insert]. Waltham, MA. Syndax Pharmaceuticals. 2024.
2Issa GC, Aldoss I, Thirman MJ, et al. Menin inhibition with revumenib for KMT2A-rearranged relapsed or refractory acute leukemia (AUGMENT-101). J Clin Oncol. Published online August 9, 2024. doi:10.1200/JCO.24.00826
3Pieters R, De Lorenzo P, Ancliffe P, et al: Outcome of infants younger than 1 year with acute lymphoblastic leukemia treated with the Interfant-06 protocol: Results from an international phase III randomized study. J Clin Oncol 37:2246-2256, 2019.